Cleared Traditional

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

K171802 · Bayer Healthcare, LLC · Neurology

Mar 2018

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K171802 is an FDA 510(k) clearance for the ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Bayer Healthcare, LLC (Whippany, US). The FDA issued a Cleared decision on March 7, 2018, 261 days after receiving the submission on June 19, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K171802 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2017
Decision Date	March 07, 2018
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

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