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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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Set for the application of EEG recording gel - 08592566001192

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
In Commercial Distribution

  • 08592566001192 ()
00-119

  • Psychophysiological biofeedback system

Disc Electrode 9mm Sn (Tin) - 08592566001161

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
mix 25pcs
In Commercial Distribution

  • 08592566001161 ()
00-116

  • Psychophysiological biofeedback system

Disc Electrode 9mm Sn (Tin) - 08592566001154

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
mix 10pcs
In Commercial Distribution

  • 08592566001154 ()
00-115

  • Psychophysiological biofeedback system

Disc Electrode 9mm Sn (Tin) - 08592566001147

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
mix 5pcs
In Commercial Distribution

  • 08592566001147 ()
00-114

  • Psychophysiological biofeedback system

Pair of Ear Electrodes Sn (Tin) - 08592566001116

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
blue, 1.5 m
In Commercial Distribution

  • 08592566001116 ()
00-111

  • Psychophysiological biofeedback system

Pair of Ear Electrodes Sn (Tin) - 08592566001109

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
white, 15 cm
In Commercial Distribution

  • 08592566001109 ()
00-110

  • Psychophysiological biofeedback system

Pair of Ear Electrodes Sn (Tin) - 08592566001093

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
white, 1.5 m
In Commercial Distribution

  • 08592566001093 ()
00-109

  • Psychophysiological biofeedback system

TruScan Neurofeedback 32ch - 08592566001048

32 channel neurofeedback device
DEYMED Diagnostic s.r.o.
TS-NFB32
In Commercial Distribution

  • 08592566001048 ()
TS-NFB32

  • Psychophysiological biofeedback system

TruScan Neurofeedback 24ch - 08592566001024

24 channel neurofeedback device
DEYMED Diagnostic s.r.o.
TS-NFB24
In Commercial Distribution

  • 08592566001024 ()
TS-NFB24

  • Psychophysiological biofeedback system

BrainFeedback Pro 2 - 08592566001017

2 channel neurofeedback device
DEYMED Diagnostic s.r.o.
BF-PRO2
Not in Commercial Distribution

  • 08592566001017 ()
BF-PRO2

  • Psychophysiological biofeedback system

nfant® Thrive Feeding System - 00196852268917

No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00196852268917 ()
NTFS

  • Psychophysiological biofeedback system

Kangaroo - 10885380198786

Kangaroo NTrainer Handpiece
Cardinal Health 200, LLC
1000NT-H
In Commercial Distribution

  • 10885380198786 ()
1000NT-H

  • Psychophysiological biofeedback system

NTRAINER - 10885380195587

NTrainer System 2.0
Cardinal Health 200, LLC
1000NT
In Commercial Distribution

  • 10885380195587 ()
1000NT

  • Psychophysiological biofeedback system

Neuroband - 00850010086033

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 - 00850010086026

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 - 00850010086019

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 - 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

Axon - 09413000077094

EEG Headset - Medium
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000077094 ()
100142

  • Psychophysiological biofeedback system

PARO Robot - 04580537541246

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

PARO Robot - 04580537541239

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

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

ViMove+ - B758000VMPLU0

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

dorsaVi - V6 Low Back AMI DAP - B758000RDA891

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

dorsaVi - V6 EMG DAP - B758000RDA890

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

dorsaVi - V6 Overwrap Adhesives - B758000RDA483

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

dorsaVi - B758000RDA482

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 / V5 Sensor Kit - B7580000VMV50

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 - B7580000PS100

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

30 Minute Disposable Application Pad - B758000035630

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

Freespira - B185SM40500

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

FST5 - B185FS059370

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 - 50885380198791

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

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

  • Psychophysiological biofeedback system
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