SEARCH RESULTS FOR: h5免签版ios免签app-(电报机器人wap2bot).lml(3049 results)
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
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
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
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians.
The device is intended for use in patients 8 years and older.
Momentum Health Inc
Momentum Spine
In Commercial Distribution
- 00628774533007 ()
- Posture imaging/analysis software
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
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
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
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
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 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
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
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
reSET-O Mobile Application runs on iOS. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only Mobile Medical Application.
Limitations of Use: reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
PEAR THERAPEUTICS, INC.
1.1
Not in Commercial Distribution
- 10851580008057 ()
N/A
- Mental health/function therapeutic software, screen-viewed
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
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
Soovu Pain Relief System is a kit branded as Soovu Heatwave Therapy and includes two 2" x 2" pods/heaters that, when adhered to user's skin via disposable adhesive rings, provide pulsed heat at controlled temperatures for set therapy durations. The pods are Bluetooth-paired with, and controlled via, a mobile device application (Soovu on iOS or Android) from which the user also administers the heat therapy sessions. The Soovu Heatwave Therapy Kit includes 2 heating pods, 1 dual-pod charging cradle, 1 USB charging cable, 60 'Daily' adhesives, carry case, and Quick Start Guide.
Soovu Labs, Inc.
SL-WPTKIT-01
In Commercial Distribution
- 00850014805005 ()
- Electric pad localized-body heating system
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441IQ0 ()
- Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTIEC0 ()
- Electrocardiograph, professional, multichannel
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG
management solution. (Medical Device Data System) The light weight and portable Spaulding
Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph)
information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or
Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and
strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a
12-lead ECG.
SPAULDING MEDICAL
2100iQ
In Commercial Distribution
- B441BTAHA0 ()
- Electrocardiograph, professional, multichannel
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 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
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
reSET Mobile Application runs on iOS. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to -
- increase abstinence from a patient’s substances of abuse during treatment, and
- increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1.5
Not in Commercial Distribution
- 10851580008026 ()
N/A
- Mental health/function therapeutic software, screen-viewed
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