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Reletex

FDA UDI

Class II (US FDA UDI)

by ReliefBand Technologies

Identity

Trade Name
Reletex FDA UDI
Generic Name
Anti-nausea transcutaneous electrical nerve stimulation wristband FDA UDI
Device Name
Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient use. FDA UDI
Model / Reference
PCN3 FDA UDI
Description
Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient use. FDA UDI

Identifiers

Catalog Number
PCN3 FDA UDI
Primary DI / UDI-DI
00661168300014 FDA UDI
510(k) Number
K994387 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

Yes

FDA UDI

Over-the-Counter

No

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

Reletex 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ReliefBand Technologies

Sources (1)

  • FDA UDI dc4ec6d2-94cb-4e4e-a58d-ee702a65b2e4 37 fields · synced May 30, 2026