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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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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
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
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
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
ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
DORSAVI LTD
000VMPLU0
In Commercial Distribution

  • B758000VMPLU0 ()
VMPLU

  • Psychophysiological biofeedback system
Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
DORSAVI LTD
V6 Low Back AMI DAP
In Commercial Distribution

  • B75800RDA866 ()
  • B758000RDA891 ()
RS-A866

  • Psychophysiological biofeedback system
Single use disposable application pad adhesive for use with dorsaVi Version 6 EMG Sensors.
DORSAVI LTD
V6 EMG DAP
In Commercial Distribution

  • B75800RDA865 ()
  • B758000RDA890 ()
RS-A865

  • Psychophysiological biofeedback system
Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
DORSAVI LTD
V6 Overwrap Adhesives
In Commercial Distribution

  • B75800RDA445 ()
  • B758000RDA483 ()
RS-A483

  • Psychophysiological biofeedback system
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