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iReliev

FDA UDI

Class II (US FDA UDI)

by Excelhealth, Inc.

Identity

Trade Name
iReliev FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
iReliev PlayMakar Therapeutic Wearable System FDA UDI
Model / Reference
ET-5050 FDA UDI
Description
iReliev PlayMakar Therapeutic Wearable System FDA UDI

Identifiers

Catalog Number
ET-5050 FDA UDI
Primary DI / UDI-DI
00853635002426 FDA UDI
510(k) Number
K161453 FDA UDI
FDA Product Code
NYN FDA UDI
NUH FDA UDI
NGX FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Transcutaneous electrical stimulation electrode, single-useAnalgesic transcutaneous electrical nerve stimulation systemTranscutaneous electrical stimulation leadArthritis TENS system

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

Similar devices

Also classified as Arthritis TENS system.

Cleared under the same submission

K161453 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Excelhealth, Inc.

Sources (1)

  • FDA UDI d51f7372-d7f5-4f89-9abb-ac62305048b0 36 fields · synced Jun 1, 2026