FDA.reportPublic FDA data

Reliefband® Premier Charcoal

Primary DI
00661168600022
Brand
Reliefband® Premier Charcoal
Company
RELIEFBAND TECHNOLOGIES LLC
Model
2.0 Charcoal
Catalog number
2.0
Device description
Reliefband® Premier Charcoal is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.
Published
2021-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30661168600023PackageGS16In Commercial Distribution
50661168600027PackageGS14In Commercial Distribution
00661168600022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3066116860002330661168600023
5066116860002750661168600027
00661168600022006611686000226611686000220661168600022

GMDN Terms#

Term, Definition table
TermDefinition
Anti-nausea transcutaneous electrical nerve stimulation wristbandAn electrically-powered device designed to be worn on the wrist of a patient to apply electrical stimuli to the median nerve through the skin (transcutaneously), to help relieve the sensation of nausea caused by various conditions [e.g., pregnancy (morning sickness), motion (travel sickness), chemotherapy]. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius38 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999gudidservice@reliefband.com

Regulatory Flags#

DUNS number
080294073
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00661168000037Reliefband® Sport - BlackRBSPT2025-02-24
00661168000044Reliefband® Sport - Soft GreyRBSPT2025-02-24
00661168000167Reliefband® 50 HoursRB502025-02-24
00661168000181Reliefband® Premier PlusRBPLUS2025-02-24
30661168800010Reliefband® Sport - BlackRBSPT2025-02-24
30661168800027Reliefband® Sport - Soft GreyRBSPT2025-02-24
10661168000164Reliefband® 50 HoursRB502025-02-24
00661168000174Reliefband® FlexRBFLX2025-02-24
10661168000188Reliefband® Premier PlusRBPLUS2025-02-24
00661168300014ReletexPCN3PCN32021-06-29
00661168600015Reliefband® Classic1.51.52021-06-29
00661168600039Reliefband® Premier Slate Blue2.0 Slate Blue2.02021-06-29
00661168190011Reliefband® Conductivity Gel GP-1GP-12021-06-29
20661168300018ReletexPCN3PCN32021-06-29
20661168600019Reliefband® Classic1.51.52021-06-29
30661168600023Reliefband® Premier Charcoal2.0 Charcoal2.02021-06-29
30661168600030Reliefband® Premier Slate Blue2.0 Slate Blue2.02021-06-29
00661168800019Reliefband® Custom USB Charging CableCC-1CC-12021-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17