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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 Size Type Device Class Implantable

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NFANT LABS LLC
1
In Commercial Distribution

  • 00196852268917 ()
NTFS

  • Psychophysiological biofeedback system
Kangaroo NTrainer Handpiece
Cardinal Health 200, LLC
1000NT-H
In Commercial Distribution

  • 10885380198786 ()
1000NT-H

  • Psychophysiological biofeedback system
NTrainer System 2.0
Cardinal Health 200, LLC
1000NT
In Commercial Distribution

  • 10885380195587 ()
1000NT

  • Psychophysiological biofeedback system
Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30SB
Not in Commercial Distribution

  • 00850010086033 ()


  • Psychophysiological biofeedback system
Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30MD
Not in Commercial Distribution

  • 00850010086026 ()


  • Psychophysiological biofeedback system
Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
DREEM
EFM00MD
Not in Commercial Distribution

  • 00850010086019 ()


  • Psychophysiological biofeedback system
Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system
Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system
EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078459 ()
100161

  • Psychophysiological biofeedback system
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