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Handheld (Bluetooth Low Energy protocol) personal wireless microphone to help hear companions easier in noisy or challenging listening environments. Used with Evok 1600 Hearing aid(s) and controlled with Persona APP as well as controls on the unit itself.
Persona Medical
Remote Microphone Wireless Streamer
In Commercial Distribution
- 00851362008131 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XS
In Commercial Distribution
- 00851362008124 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VS
In Commercial Distribution
- 00851362008117 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XR
In Commercial Distribution
- 00851362008100 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VR
In Commercial Distribution
- 00851362008094 ()
- Air-conduction hearing aid, behind-the-ear
Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional.
Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional.
The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient.
The device’s BLE ports connect to the following:
1. Abdominal patch
2. Thoracic patch
3. Pulse oximeter
Data from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter.
This Device Identification is for a kit that is shipped without a charger.
Tatch Inc.
WSWW-RE-K-N-V02-BLO
In Commercial Distribution
- 00860007837029 ()
- Polysomnograph
The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU™ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA).
The INVU by Nuvo™ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Band™) that connects wirelessly to the INVU™ App installed on the pregnant person’s mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant person’s medical supervisor. The INVU™ App installed on the pregnant person’s smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVU™ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Pro™ web application.
Nuvo Group Usa, Inc.
NV-INVU-0001
In Commercial Distribution
- 07290018250044 ()
INVU 3200
- Foetal/maternal prenatal monitor
Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT2S
In Commercial Distribution
- 00851362008551 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT1R
In Commercial Distribution
- 00851362008452 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT2R
In Commercial Distribution
- 00851362008353 ()
- Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
BT1S
In Commercial Distribution
- 00851362008346 ()
- Air-conduction hearing aid, behind-the-ear
ENHANCED ALGORITHM ECG EVENT RECORDER
BRAEMAR MANUFACTURING, LLC
900-0557-06
In Commercial Distribution
- B146ER9R0 ()
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&
- Electrocardiography telemetric monitoring system
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution
- 08625630003027 ()
- Length: 30 Millimeter
- Length: 35 Millimeter
- Length: 40 Millimeter
- Length: 45 Millimeter
- Length: 50 Millimeter
- Length: 55 Millimeter
- Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511
- Intraurethral valve/pump
106900 Connex Server Application Software – Includes 2 thumb drives, one Production, one Test, with included software app, installer and Proview – Includes one ADT <(>&<)> one ORU production license, one ADT <(>&<)> one ORU test license – Includes 5 connectivity device test licenses – Includes Connex CS 1.8x DFU
WELCH ALLYN, INC.
901066
In Commercial Distribution
- 00732094244298 ()
106900
- Centralized patient monitor
Standard Imaging Stereotactic Dose Verification Phantom can be used for a wide variety of tests including routine absolute dosimetry output checks and treatment planning system(TPS) commissioning and quality assurance(QA) tests as recommended by TG 53 and IEC 430 Treatment Planning System Commissioning and QA Standards. Patient specific dosimetry tests can be performed easily as well.
STANDARD IMAGING INC.
91250
In Commercial Distribution
- 00850019946529 ()
91250
- Multi-modality therapeutic radiation phantom, test object
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.
ASCENSIA DIABETES CARE US INC.
7818
Not in Commercial Distribution
- 00301937818011 ()
- 0193-7818-01 ()
- 40301937818019 ()
85012037
- Glucose monitoring system IVD, home-use
The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
Model E4
In Commercial Distribution
- 00863609000310 ()
- Electronic acoustic stethoscope
The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tubed stethoscopes including LittmannTM, Welch AllynTM, MDFTM, and ADCTM. The Eko Core Attachment wirelessly pairs to the free Eko mobile app for recording, visualization, sharing, and annotation of sounds.
Eko Devices, Inc.
E6
In Commercial Distribution
- 00850010298009 ()
- Electronic acoustic stethoscope
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
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
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