FDA.reportPublic FDA data

Reliefband® 50 Hours

Primary DI
00661168000167
Brand
Reliefband® 50 Hours
Company
RELIEFBAND TECHNOLOGIES LLC
Model
RB50
Device description
Reliefband® 50 Hours is a therapeutic device incorporated into a wristband which has stimulating electrodes that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Reliefband 50 Hours offers fifty hours of treatment time. The batteries of Reliefband® 50 Hours are non-replaceable.Reliefband® 50 Hours is a wearable device indicated for use in the treatment of nausea and vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy, as well as an adjunct to antiemetics in reducing post-operative nausea.
Published
2025-02-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191547000ReliefBandReliefband Technologies, LLC2019-08-30GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661168000164PackageGS112In Commercial Distribution
20661168000161PackageGS14In Commercial Distribution
00661168000167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066116800016410661168000164
2066116800016120661168000161
00661168000167006611680001676611680001670661168000167

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
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
00661168600022Reliefband® Premier Charcoal2.0 Charcoal2.02021-06-29
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
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
00815290019416ePower® T2 DIGITAL TENSCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17