iReliev

FDA UDI

Class II (US FDA UDI)

by Excelhealth, Inc.

Identity

Trade Name: iReliev FDA UDI
Generic Name: Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name: iReliev TENS Pain Relief System, 40 per Case FDA UDI
Model / Reference: ET-1313 FDA UDI
Description: iReliev TENS Pain Relief System, 40 per Case FDA UDI

Identifiers

Catalog Number: ET-1313 FDA UDI
Primary DI / UDI-DI: 00853635002037 FDA UDI
510(k) Number: K091757 FDA UDI
FDA Product Code: GXY FDA UDI
NUH FDA UDI
GMDN Term: Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1320 FDA UDI
882.5890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Transcutaneous electrical stimulation electrode, single-use Analgesic transcutaneous electrical nerve stimulation system Transcutaneous electrical stimulation lead

iReliev by Excelhealth, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091757 also covers:

PURE ENRICHMENT — BEAR DOWN CONSULTING
Zewa — VERIDIAN HEALTHCARE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Excelhealth, Inc.

Sources (1)

FDA UDI 95319fad-9c5c-49a5-bae1-0f1e3c59c475 36 fields · synced May 30, 2026