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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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PARO Robot - 04580537541222

A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medical Device 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 Gold
In Commercial Distribution

  • 04580537541222 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541215

A baby seal type robot with artificial intelligence Neurological Therapeutic Medical Device 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 White
In Commercial Distribution

  • 04580537541215 ()
V9-14UC

  • Psychophysiological biofeedback system

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

Axon 2 - 09413000095982

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

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Axon - 09413000078459

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

Axon - 09413000078442

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

Axon - 09413000078435

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

Axon - 09413000078428

EEG Headset - Large
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078428 ()
100143

  • Psychophysiological biofeedback system

Axon - 09413000078411

EEG Headset - Small
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078411 ()
100141

  • Psychophysiological biofeedback system
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