Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
VG01
In Commercial Distribution

  • 05391548420036 ()
  • 05391548420029 ()
  • 05391548420043 ()
VGHS01

  • Biomechanical function analysis/rehabilitation software
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
2.2.0
Not in Commercial Distribution

  • 05391548420012 ()
VGCP01

  • Biomechanical function analysis/rehabilitation software
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress.
DIGITAL REHABILITATION LIMITED
2
In Commercial Distribution

  • 05391548420005 ()
VGAPP01

  • Biomechanical function analysis/rehabilitation software
MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, electrode lead wire, electrodes and leg brace. It can control the timing and duration of the stimulation by tracing the angle during walking. It uses FES (functional electrical stimulation) to treat and improve the patient's foot drop to help the patient improve their walking ability.
MyndTec Inc
MyndStep Foot Drop Stimulator
In Commercial Distribution

  • 00692520001027 ()
800102

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software
Handsfree (Bluetooth) use of hearing aids with TV or other devices with AUX output. Also, can be used as a remote microphone to help hear companions easier in noisy or challenging listening environments. Used with Sombra XR, VR, XS, VS & X9 models. Hearing aid(s) and controlled with Persona APP as well as controls on the unit itself.
Persona Medical
Freelink Multistreamer
In Commercial Distribution

  • 00851362008186 ()


  • Air-conduction hearing aid, behind-the-ear
Matrx MAC-HUG Back Support. 300lb. Weight Capacity. Each Matrx MAC-HUG Backs come with two configurable MAC Lateral Contour Supports (available in 3 optional contour depths) to allow for precise orientation within the wheelchair for optimal positioning and postural support. The MAC-HUG Back incorporates our unique StaminaFibre ® insert for maximum immersion/envelopment and increased comfort.https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Motion Concepts Inc
MAC-HUG
In Commercial Distribution

  • 07540147001391 ()
MACwwhh-HUG

  • Wheelchair back rest
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.
ASCENSIA DIABETES CARE US INC.
9763
Not in Commercial Distribution

  • 40301939763010 ()
  • 00301939763012 ()
  • 0193-9763-01 ()
85012088

  • Glucose monitoring system IVD, home-use
The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. ReliOn Premier BLU is a full feature blood glucose monitoring system featuring Bluetooth Smart technology. Wireless Bluetooth technology connects the meter to a cloud based portal through ReliOn Life app you download onto your smart phone.
WAL-MART STORES, INC.
782001
In Commercial Distribution

  • 10194346136657 ()
  • 00194346136650 ()
N/A

  • Glucose monitoring system IVD, home-use
The PRiO is an iPad based communication tool featuring the iPad Air and the popular LAMP Words for Life (WFL) Vocabulary. LAMP WFL is a full vocabulary communication app that combines the power of UNITY with the principles and strategies of Language Acquisition through Motor Planning (LAMP). The WFL vocabulary is appropriate for individuals with a wide range of language and communication skills.
PRENTKE ROMICH COMPANY
PRiO
In Commercial Distribution

  • 00858526006576 ()

  • Weight: 1.9 Pound


  • Voice synthesizer/digitizer
The ReliOn Premier BLU Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. ReliOn Premier BLU is a full feature blood glucose monitoring system featuring Bluetooth Smart technology. Wireless Bluetooth technology connects the meter to a cloud based portal through ReliOn Life app you download onto your smart phone.
WAL-MART STORES, INC.
782001
In Commercial Distribution

  • 10681131169803 ()
  • 00681131169806 ()


  • Glucose monitoring system IVD, home-use
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840022 ()


  • Self-care monitoring/reporting software
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
iOS
In Commercial Distribution

  • 04260749840015 ()


  • Self-care monitoring/reporting software
The PRiO is an iPad based communication tool featuring the 9.7" iPad PRO and the popular LAMP Words for Life (WFL) Vocabulary. LAMP WFL is a full vocabulary communication app that combines the power of UNITY with the principles and strategies of Language Acquisition through Motor Planning (LAMP). The WFL vocabulary is appropriate for individuals with a wide range of language and communication skills.
PRENTKE ROMICH COMPANY
PRiO-13
In Commercial Distribution

  • 00858526006620 ()

  • Weight: 1.9 Pound


  • Voice synthesizer/digitizer
The PRiO-mini is an iPad based communication tool featuring the iPad-mini and the popular LAMP Words for Life (WFL) Vocabulary and iPad-mini. LAMP WFL is a full vocabulary communication app that combines the power of UNITY with the principles and strategies of Language Acquisition through Motor Planning (LAMP). The WFL vocabulary is appropriate for individuals with a wide range of language and communication skills.
PRENTKE ROMICH COMPANY
PRiO-mini
In Commercial Distribution

  • 00858526006569 ()

  • Weight: 1.4 Pound


  • Voice synthesizer/digitizer
The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it. The SPM01M1 configuration supports Bluetooth Low Energy communication. In this case it can connect directly to a smartphone/tablet on which a dedicated app is installed. The dedicated control software is supplied via an usb receiver and must be used by a properly trained healthcare professional.
NCS LAB SRL
SPM01M1
In Commercial Distribution

  • 08051122040902 ()
SPM01M1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentration of 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSH combines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.
Sugentech Inc._Osong Branch
Surearly SMART Menopause Test
In Commercial Distribution

  • 08809408863475 ()
  • 08809408863512 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
BabySat unit composed of one base station, one sensor, two socks and the App. The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment
Owlet Baby Care, Inc.
OSS 3.0-M1; OBL 3.0-M1
In Commercial Distribution

  • 00810099090086 ()
  • 00810099090192 ()
  • 10810099090199 ()


  • Multiple vital physiological parameter monitoring system, home-use
The overall intended use of neotivCare is to provide an app-based objective measurement of cognition to quantify cognitive impairment. The software is intended for use by patients at the indication of medical professionals to quantify and monitor a suspected or self-reported cognitive impairment. The app is not intended as a standalone diagnostic assessment and is only indicated as a tool to support the diagnostic process of a medical professional.
neotiv GmbH
1.0.0
In Commercial Distribution

  • 04262390860015 ()


  • Cognitive assessment software
The TempShield is a wearable device that senses body temperature and communicates with an app on your smartphone. When the TempShield is connected to your device, it sends all temperature measurements automatically. You can wear an TempShield for up to 60 days and check your current temperature and temperature measurements history at any time. You have the ability to share the data with your clinician if your clinician has established an AION account.
Aion Biosystems, Inc.
DWF-1824
In Commercial Distribution

  • 00197644811199 ()


  • Wireless patient thermometer, single-use
Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution

  • 00860007260605 ()


  • Neurodevelopmental disorder interpretive software
The Surearly SMART Ovulation Test works by inserting the test stick into the test reader, which measures color changes on the test stick. It detects LH (10 mIU/mL or greater) and Progesterone metabolites (5 ug/mL or greater) in urine. Monoclonal LH antibodies and P3G-BSA conjugate with anti-P3G antibodies are immobilized on test lines 1 and 2 respectively. The test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, LH and P3G combine with antibody gold conjugates on the gold conjugate pad. The antigen-antibody complexes react with anti-LH antibody on test line 1 and P3G-BSA on test line 2, forming red or purple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, Surearly SMART Ovulation Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graph and additional messages to help your comprehensive management of hormone cycle.
Sugentech Inc._Osong Branch
Surearly SMART Ovulation Test
In Commercial Distribution

  • 08809408863482 ()
  • 08809408863529 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
Sugentech Inc._Osong Branch
Surearly SMART (SSMD001E)
In Commercial Distribution

  • 08809408863499 ()


  • Immunoassay reagent vehicle reader IVD
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Long
In Commercial Distribution

  • 00840295405582 ()


  • Sequential venous compression system inflator
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Regular
In Commercial Distribution

  • 00840295405575 ()


  • Sequential venous compression system inflator
RecoveryAir JetBoots Pro is a pair of pneumatic compression boots that incorporate vibration and IR technologies. These new features will enhance recovery of legs throughout their combination in different preset programs. The device is designed to work in pairs with a master boot, with a main control panel, and a dummy boot. Additionally, it will be Bluetooth enabled to connect with the Therabody App where user can access to more settings, presets, and track overall usage
Therabody, Inc.
JetBoots PRO Plus Short
In Commercial Distribution

  • 00840295405568 ()


  • Sequential venous compression system inflator
CORE.PORTAL Establishes the connection between the intra-operative networks and the hospital-wide IT systems.Provides various services centrally in all operating rooms. Included are: Installation service Receiving and forwarding of patient lists by means of DICOM WORKLIST. Receiving and forwarding of images and videos by means of DICOM STORE. Intraoperative management of recorded images and videos using MEDIA ARCHIVE APP. A server, which provides the virtual environment with the ESXi operating system, is required for installation. The server hardware is not part of the Richard Wolf portfolio and must be provided by customers on their own.
Richard Wolf GmbH
5597101
In Commercial Distribution

  • 04055207058848 ()
5597101

  • Operating room audiovisual data/device management system application software
The Home Vision Monitor® Model 0005 is a vision function test provided as a downloadable app on to the user’s supplied cell phone or tablet. The Home Vision Monitor® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
VITAL ART AND SCIENCE, LLC
Model 0005
Not in Commercial Distribution

  • 00860004152705 ()


  • Vision testing/training chart
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
EVA 3 Plus/EVA 3.1
In Commercial Distribution

  • 17290016976547 ()
  • 17290016976028 ()
  • 17290016976523 ()
  • 17290016976516 ()
  • 17290016976509 ()


  • Colposcope
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
3.0
In Commercial Distribution

  • 17290016976011 ()


  • Colposcope
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution

  • 17290016976004 ()


  • Colposcope
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE blood glucose meter; 10 CONTOUR® NEXT blood glucose test strips; Lancing Device; 10 Colored MICROLET® lancets (provided sterile); User Guide (including CONTOUR® DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT control solution. A clear endcap is available for Alternative Site Testing (AST). It may not be included in your meter kit. If you perform AST and need a clear endcap (for palm), contact Diabetes Care Customer Service.
ASCENSIA DIABETES CARE US INC.
9767
Not in Commercial Distribution

  • 40301939767018 ()
  • 00301939767010 ()
  • 0193-9767-01 ()
85977059

  • Glucose monitoring system IVD, home-use
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution

  • 00857335005121 ()
  • 57335-0005-12 ()
57335000512

  • Mental health/function therapeutic software, screen-viewed
The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls.
Steth IO
1.0
In Commercial Distribution

  • 00860135001958 ()


  • Electronic acoustic stethoscope
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that opehttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageDataLoaded=false&pageMode=create#rates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery
FOTONA d.o.o.
M021-5AF/2 STAND
Not in Commercial Distribution

  • 03830054230491 ()


  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
  • Dental solid-state laser system
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0065
In Commercial Distribution

  • D83600650 ()
0065

  • Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0064
In Commercial Distribution

  • D83600640 ()
0064

  • Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0063
In Commercial Distribution

  • D83600630 ()
0063

  • Dental composite resin
Orion in the chemical cure form is a paste/paste system. The dentist has a choice of using self or light-cure form, depending upon the clinical situation. There is a virtually unlimited working time in the lhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930859#ight-cure form, and a convenient working time in the self-cure (chemical) form. It is moldable and non-sticky yet has an adhesive consistency. Material has well-balanced x-ray opacity that permits easy distinguishing from tooth structure, pins and posts. It contains moderately hard filler for easier carving and shaping. The standard Orion kit comes in two shades: the contrasting one, for easy distinguishing from the tooth structure; the other is tooth colored for use under shell crowns.
DENT ZAR, INC.
0062
In Commercial Distribution

  • D83600620 ()
0062

  • Dental composite resin
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or forhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301830# hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution

  • 00745129188863 ()

  • Pressure,30-40 mmHg
923CSSM99

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fithttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301826#ted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution

  • 00745129188849 ()

  • Pressure,30-40 mmHg
923CMSM99

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301808#
SIGVARIS INC
923C
In Commercial Distribution

  • 00745129188832 ()

  • Pressure,30-40 mmHg
923CLLM99

  • Compression/pressure sock/stocking, single-use
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution

  • 03770018808239 ()
SBM1AA018

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS
In Commercial Distribution

  • B786SBM1AA1100 ()
SBM1AA110

  • Analgesic transcutaneous electrical nerve stimulation system
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS standard kit
In Commercial Distribution

  • B786SBM1AA0170 ()
SBM1AA017

  • Analgesic transcutaneous electrical nerve stimulation system
Expand your communication options with a set of three BIG TalkingBrix speech devices. Pressing the large colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Add strategically around the classroom or home to provide on-the-spot communication Use together to make choices Use with multiple individuals at one time to provide each with a unique communication message Features High-quality sound suitable for almost any environment Long-lasting rechargeable battery Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the BIG TalkingBrix. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device
Ablenet, Inc.
10000050
In Commercial Distribution

  • 00850011150184 ()
10000050

  • Assistive speech generator
Expand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Add strategically around the classroom or home to provide on-the-spot communication Use together to make choices Use with multiple individuals at one time to provide each with a unique communication message Features High-quality sound suitable for almost any environment Long-lasting rechargeable battery Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000032
In Commercial Distribution

  • 00186648000524 ()
10000032

  • Assistive speech generator
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
OCULOCARE medical AG
3.2.12
In Commercial Distribution

  • EOMA32120 ()


  • Vision self-testing software
The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Use for yes and no responses Choose between two options of food, drink, or activities Provide a way to make two unique requests like "I need help" and "I'm done" Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000045
In Commercial Distribution

  • 00850011150108 ()
10000045

  • Assistive speech generator
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Provide a unique response to a question like "What is the weather like outside?" Respond to an assessment Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty" Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution

  • 00186648000531 ()
10000028

  • Assistive speech generator
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