Reliefband® Sport - Black

Primary DI
30661168800010
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 at the 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 over the counter use.
Published
2025-02-24
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
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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999gudidservice@reliefband.com

Regulatory Flags#

DUNS number
080294073
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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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