DEVICE: Reliefband® Sport - Black (00661168000037)

Device Identifier (DI) Information

Reliefband® Sport - Black
RBSPT
In Commercial Distribution

RELIEFBAND TECHNOLOGIES LLC
00661168000037
GS1

1
080294073 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
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No

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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K191547 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

cc6d72dd-ecb2-4203-aa34-9090224a93b1
March 04, 2025
1
February 24, 2025
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
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Customer Contact

[?]
9999999999
gudidservice@reliefband.com
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