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iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurement
technology to an international 10-20 system compliant size-adjustable headset.
iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLE
wireless connection to the iSyncWaveTM App. The data is displayed and recorded via the
iSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require a
preparation process(e.g., applying conductive gel), to obtain high quality EEG signals.
Before measuring the EEG, you can check the impedance of each electrode under the
impedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digital
converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and
then converted to digital data at 24-bit resolution.
This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and
1 ground electrode. The measured data can be digitally converted to common average,
longitudinal and transverse montage. The measured data is automatically uploaded to
a secure cloud server via Wi-Fi connection and saved securely. The data saved in the
cloud server can be seen on the iSyncWaveTM app.
iSyncWaveTM can be only used by professional and/or medical personnel with product
training and experience in EEG measurement. The professional and/or medical
personnel can check the signal quality in real time and refer to the measured data in
clinical practice.
iMediSync, Inc.
ISW-MUS101
In Commercial Distribution
- 08800108500363 ()
- Electroencephalograph
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose.
Kit contains: CONTOUR® NEXT ONE Meter; 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.
9765
In Commercial Distribution
- 40301939765014 ()
- 00301939765016 ()
- 0193-9765-01 ()
85602314
- Glucose monitoring system IVD, home-use
TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package.
PRENTKE ROMICH COMPANY
TCE10.2
In Commercial Distribution
- 00816486020766 ()
- Voice synthesizer/digitizer
TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package
PRENTKE ROMICH COMPANY
TCE10.1
In Commercial Distribution
- 00816486020544 ()
- 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; 20 CONTOUR® NEXT Blood Glucose Test Strips; Lancing Device; 20 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card.
ASCENSIA DIABETES CARE US INC.
7824
Not in Commercial Distribution
- 40301937824010 ()
- 00301937824012 ()
- 0193-7824-01 ()
90001779
- Glucose monitoring system IVD, home-use
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
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
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