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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
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
Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
DORSAVI LTD
V6 Sensor Adhesive
In Commercial Distribution

  • B758000RDA482 ()
  • B758000RDA441 ()
RS-A482

  • Psychophysiological biofeedback system
Movement Suite 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
0000VMV50
In Commercial Distribution

  • B7580000VMV50 ()
VMV50

  • Psychophysiological biofeedback system
Professional Suite 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
0000PS100
In Commercial Distribution

  • B7580000PS100 ()
PS100

  • Psychophysiological biofeedback system
Single use disposable application pad adhesive for use with dorsaVi Version 5 MDM Sensors for Movement Suite Kits.
DORSAVI LTD
30Min-DAP
In Commercial Distribution

  • B758000035630 ()
  • B758000RDA326 ()
0356-30

  • Psychophysiological biofeedback system
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
3
In Commercial Distribution

  • B185SM40500 ()
04275

  • Psychophysiological biofeedback system
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


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

  • 10885380198793 ()
  • 50885380198791 ()
1000NT-T

  • Psychophysiological biofeedback system
NTrainer System 2.0 Patient Receiver Tubes (10-pack)
Cardinal Health 200, LLC
510NT
In Commercial Distribution

  • 10885380195556 ()
  • 50885380195561 ()
510NT

  • Psychophysiological biofeedback system
NTrainer System 2.0 Patient Receiver Tubes (5-pack)
Cardinal Health 200, LLC
505NT
In Commercial Distribution

  • 10885380195556 ()
  • 50885380195554 ()
505NT

  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA9005
In Commercial Distribution

  • 07540191000616 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA9003
In Commercial Distribution

  • 07540191000609 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA7904
In Commercial Distribution

  • 07540191000562 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA2076
In Commercial Distribution

  • 07540191000531 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA2000M
In Commercial Distribution

  • 07540191000524 ()


  • Psychophysiological biofeedback system
No Description
Thought Technology Ltd.
SA2050M
In Commercial Distribution

  • 07540191000517 ()


  • Psychophysiological biofeedback system
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