Cleared Traditional

K171802 - ALEVE Direct Therapy (ALEVE Direct Ther...

K171802 is an FDA 510(k) clearance for ALEVE Direct Therapy (ALEVE Direct Ther..., manufactured by Bayer Healthcare, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K171802 · Bayer Healthcare, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
261d
Days
Class 2
Risk

K171802 is an FDA 510(k) clearance for the ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Whippany, US). The FDA issued a Cleared decision on March 7, 2018 after a review of 261 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K171802

510(k) Number K171802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 148d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 157
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K171802.
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
K180956 · Shenzhen Roundwhale Technology Co. , Ltd. · Jun 2018
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K181207 · Everyway Medical Instruments Co., Ldt. · Jun 2018
EV-804 OTC Pain Relief TENS
K172919 · Everyway Medical Instruments Co.,Ltd · Apr 2018
Wireless Pain Relieve Device Model: LT5018C
K173462 · Shenzhen Dongdixin Technology Co., Ltd. · Dec 2017
Avail
K172079 · Omron Healthcare, Inc. · Oct 2017
OTC Combo TENS/EMS System
K172809 · Well-Life Healthcare Limited · Oct 2017