Palm TENS

FDA 510(k) K150308 · Heat IN A Click, LLC

Substantially Equivalent

510(k) numberK150308

Submission

Device name
Palm TENS
Applicant
Heat IN A Click, LLC
Dania, FL, US
Received
February 9, 2015
Decision date
October 20, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

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Questions and answers

When was Palm TENS cleared by the FDA?

Palm TENS (K150308) received a 510(k) decision of Substantially Equivalent on October 20, 2015, 253 days after the submission was received.

What is the product code of K150308?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.