FDA.reportPublic FDA data

Reletex

Primary DI
00661168300014
Brand
Reletex
Company
RELIEFBAND TECHNOLOGIES LLC
Model
PCN3
Catalog number
PCN3
Device description
Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient use.
Published
2021-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K994387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994387000RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc.2000-03-16GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661168300011PackageGS18In Commercial Distribution
20661168300018PackageGS16In Commercial Distribution
00661168300014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066116830001110661168300011
2066116830001820661168300018
00661168300014006611683000146611683000140661168300014

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 Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9999999999gudidservice@reliefband.com

Regulatory Flags#

DUNS number
080294073
Device count
1
Lot or batch
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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