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Reliefband® Flex

FDA UDI

Class II (US FDA UDI)

by ReliefBand Technologies

Identity

Trade Name
Reliefband® Flex FDA UDI
Generic Name
Anti-nausea transcutaneous electrical nerve stimulation wristband FDA UDI
Device Name
Reliefband® Flex is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 350+ hours of active use at power level 3 or below. The batteries of Reliefband® Flex are user replaceable. Replace batteries in unit when they become drained. FDA UDI
Model / Reference
RBFLX FDA UDI
Description
Reliefband® Flex is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 350+ hours of active use at power level 3 or below. The batteries of Reliefband® Flex are user replaceable. Replace batteries in unit when they become drained. FDA UDI

Identifiers

Primary DI / UDI-DI
00661168000174 FDA UDI
510(k) Number
K191547 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Anti-nausea transcutaneous electrical nerve stimulation wristband FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Anti-nausea transcutaneous electrical nerve stimulation wristband

Reliefband® Flex by ReliefBand Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anti-nausea transcutaneous electrical nerve stimulation wristband.

Cleared under the same submission

K191547 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ReliefBand Technologies

Sources (1)

  • FDA UDI b3819c50-95df-4f45-a633-55059d46b60b 36 fields · synced Jun 6, 2026