Cleared Traditional

Palm TENS

K150308 · Heat IN A Click, LLC · Neurology

Oct 2015

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K150308 is an FDA 510(k) clearance for the Palm TENS, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Heat IN A Click, LLC (Dania, US). The FDA issued a Cleared decision on October 20, 2015, 253 days after receiving the submission on February 9, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K150308 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2015
Decision Date	October 20, 2015
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles