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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

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.

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.

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.

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

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

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

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.

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.

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.

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.

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.

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.

BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.

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.

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.

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.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viral-bacterial filter protecting the patient from the internal components of the device. The device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician’s computer via the STS software/App.

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.

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.

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.

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.

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

The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing. The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP. The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their HCP when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing. The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP. The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their HCP when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing. The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP. The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their HCP when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

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.

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.

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#

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.

"The Myolift QT+ is a Microcurrent, handheld, and mobile application based device, and easy to operate. The application used with this device will support both the types of users iPhone® and Android™. The User has to download the application via Google Play™ store (Android) /App Store® (iOS) and connect the device via Bluetooth of their phone and make their profiles accordingly. The purpose of this device is to lift and tone the face and neck. It is a battery-powered device used with conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user. Myolift QT+ has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port"

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.

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.

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

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.

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.

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.

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.

Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930708#reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess.

The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partialhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=536963#ly or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap. The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.