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 Class Implantable

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Nova Chat 8.2 is a speech generating device with an 8 inch screen. NOVA chat 8 is a communication system that offers the well-known Chat software on an Android platform. Like all "Chats," NOVA chat 8 offers a durable yet sleek portable design, with features that include an 8" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features.
PRENTKE ROMICH COMPANY
NC8.2
Not in Commercial Distribution

  • 00816486020209 ()

  • Weight: 1.35 Pound


  • Voice synthesizer/digitizer
Nova Chat 10.6 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10" display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. Now also available in an Active case.
PRENTKE ROMICH COMPANY
NC10.6
In Commercial Distribution

  • 00816486020780 ()


  • Voice synthesizer/digitizer
Nova chat 5.3 is a speech generating device with a 5 inch screen. The NC5.3 is our smallest integrated communication system that offers the well-known Chat software on an Android platform. Like all "Chats," NOVA chat 5 offers a durable yet sleek portable design, with features that include a 5" display, multiple position capabilities, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features.
PRENTKE ROMICH COMPANY
NC5.3
In Commercial Distribution

  • 00816486020193 ()

  • Weight: .55 Pound


  • Voice synthesizer/digitizer
"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"
SYRMA JOHARI MEDTECH LIMITED
Myolift QT+
In Commercial Distribution

  • 08908008085499 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.
Mianyang Meike Electronic Equipment Co., Ltd.
PBSV7.1
In Commercial Distribution

  • 06940912716016 ()


  • Hand-held ultrasound imaging system, body-surface
Nova Chat 12.1 is a speech generating device with a 12 inch screen. The Nova chat 12 has a 12.2 inch LCD display- the largest in the Chat line of products. It is a speech-generating device that offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 12 offers a durable yet sleek, portable design, with features that include a built-in camera, single or dual switch scanning, Social Chat, IVONA speech synthesizer, and many other exciting features
PRENTKE ROMICH COMPANY
NC12.1
In Commercial Distribution

  • 00816486020537 ()

  • Weight: 2.85 Pound


  • Voice synthesizer/digitizer
The NeuroSync EYE-SYNC device is a portable, fully enclosed eye tracking environment with two primary components: 1. Eye Tracker (head-mounted device) with eye tracking sensor and display 2. Android Tablet The eye tracker is a Pico Neo 3 Pro Eye with embedded sensors provided by Tobii Tech. It is mounted to the subject's face and held in place using a strap. The eye tracking sensor includes two cameras (one for each eye) to capture eye movement data. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. The integrated display within the headset provides a binocular visual field and operates as part of the standalone VR system, running on Qualcomm Snapdragon XR2 hardware. The headset processes eye-tracking data internally and supports USB-C connectivity. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance.
NEUROSYNC INC.
X03
In Commercial Distribution

  • 00860013612900 ()


  • Vision physiology/eye movement analysis system
  • Eye-tracking neurological/brain injury assessment device
App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control
reSET-O Mobile Application runs on Android. 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

  • 10851580008064 ()
N/A

  • Mental health/function therapeutic software, screen-viewed
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
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