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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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Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000078442 ()
100160

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

  • 09413000078435 ()
100140

  • Psychophysiological biofeedback system
EEG Headset - Large
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078428 ()
100143

  • Psychophysiological biofeedback system
EEG Headset - Small
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078411 ()
100141

  • Psychophysiological biofeedback system
EEG Headset - Medium
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000077094 ()
100142

  • 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
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
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
A baby seal type robot with artificial intelligence in light Pink Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Pink
In Commercial Distribution

  • 04580537541246 ()
V9-14UC

  • Psychophysiological biofeedback system
A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Charcoal Gray
In Commercial Distribution

  • 04580537541239 ()
V9-14UC

  • Psychophysiological biofeedback system
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