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iReliev

FDA UDI

Class II (US FDA UDI)

by Excelhealth, Inc.

Identity

Trade Name
iReliev FDA UDI
Generic Name
Arthritis TENS system FDA UDI
Device Name
iReliev PlayMakar Expandable Wireless Pods FDA UDI
Model / Reference
ET-5555 FDA UDI
Description
iReliev PlayMakar Expandable Wireless Pods FDA UDI

Identifiers

Catalog Number
ET-5555 FDA UDI
Primary DI / UDI-DI
00853635002440 FDA UDI
510(k) Number
K161453 FDA UDI
FDA Product Code
NYN FDA UDI
NUH FDA UDI
NGX FDA UDI
GMDN Term
Arthritis TENS system 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 systemArthritis 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 ad6ee07d-7883-43c8-9acb-bf78e0ced510 36 fields · synced May 30, 2026