DEVICE: Reliefband® Sport - Black (00661168000037)
Device Identifier (DI) Information
Reliefband® Sport - Black
RBSPT
In Commercial Distribution
RELIEFBAND TECHNOLOGIES LLC
RBSPT
In Commercial Distribution
RELIEFBAND TECHNOLOGIES LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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63388 | Anti-nausea transcutaneous electrical nerve stimulation wristband |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191547 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 0 and 38 Degrees Celsius |
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity |
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cc6d72dd-ecb2-4203-aa34-9090224a93b1
March 04, 2025
1
February 24, 2025
March 04, 2025
1
February 24, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30661168800010 | 6 | 00661168000037 | In Commercial Distribution | Inner | |
50661168800014 | 4 | 30661168800010 | In Commercial Distribution | Master |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9999999999
gudidservice@reliefband.com
gudidservice@reliefband.com