FDA.reportPublic FDA data

Neuroband

Primary DI
00850010086026
Brand
Neuroband
Company
DREEM
Model
GFM30MD
Device description
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.
Published
2021-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010086026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010086026008500100860268500100860260850010086026

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266283476
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010086033NeurobandGFM30SB2021-09-20
00850010086019Dreem 2EFM00MD2019-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260242060200DIERS iEMGDIERS International GmbHHCC2026-03-09
00852168008004LIFE SystemHARMONIC ENERGETIC TECHHCC2026-03-05
07290019255055SCENTIFIC Respiratory BiofeedbackAPPSCENT MEDICAL LTDHCC2026-02-16
08719481550165NeXus Q24Mind Media Europe B.V.HCC2025-12-03
00860001790849InTandemMedrhythms, Inc.HCC2025-10-14
00860001790856MoviveMedrhythms, Inc.HCC2025-10-14
00860001790825InTandem Education UnitMedrhythms, Inc.HCC2025-06-13
00860001790832Movive Education UnitMedrhythms, Inc.HCC2025-06-13
10885380198786KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198878KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198885KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198892KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198908KangarooCardinal Health 200, LLCHCC2025-03-12
10885380200199KangarooCardinal Health 200, LLCHCC2025-03-12
10885380198793KangarooCardinal Health 200, LLCHCC2025-03-12
00860001790818MoviveMedrhythms, Inc.HCC2025-03-10
B185FS059370FST5Freespira, Inc.HCC2025-01-23
09413000107500AxonEXSURGO LIMITEDHCC2025-01-15
07540191000647BioGraph Infiniti Advanced ReportingThought Technology Ltd.HCC2024-12-12
00855846007245MyoPro 2x Assembly KitMyomo, Inc.HCC2024-12-11
00855846007252MyoPro 2x Assembly KitMyomo, Inc.HCC2024-12-11
00855846007238Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.HCC2024-10-11
00855846007191Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.HCC2024-10-11
00855846007214MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007221MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007177MyoPro 2xMyomo, Inc.HCC2024-09-20
00855846007184MyoPro 2xMyomo, Inc.HCC2024-09-20
00092237626573Richmar EMG SoftwareCOMPASS HEALTH BRANDS CORP.HCC2024-06-28
00851679007360Trigno Avanti SensorDELSYS, INC.HCC2024-05-06
00851679007377Trigno CentroDELSYS, INC.HCC2024-05-06