FDA.reportPublic FDA data

Reliefband® Sport - Black

Primary DI
00661168000037
Brand
Reliefband® Sport - Black
Company
RELIEFBAND TECHNOLOGIES LLC
Model
RBSPT
Device description
Reliefband® Sport is a rechargeable, digital therapeutic device that has stimulating electrodes and is worn on the underside of the wrist by attaching to a wristband (included). It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. A fully charged battery will last for approximately 25 hours of continuous use atthe mid-power level or below.Reliefband® Sport is indicated for use in the treatment of nausea and vomiting associated with physician-diagnosed migraines, hangovers, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. Reliefband® Sport is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For overthe counter use.
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
30661168800010PackageGS16In Commercial Distribution
50661168800014PackageGS14In Commercial Distribution
00661168000037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3066116880001030661168800010
5066116880001450661168800014
00661168000037006611680000376611680000370661168000037

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
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
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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00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
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