Cleared Traditional

K152852 - ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)

K152852 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 84-day FDA review.

K152852 · Bayer Healthcare, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
84d
Days
Class 2
Risk

K152852 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 December 22, 2015 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K152852

510(k) Number K152852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date December 22, 2015
Days to Decision 84 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
65d faster than avg
Panel avg: 149d · This submission: 84d
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 229
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K152852.
LL TENS 160A, LL TENS 160B
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Quell
K152954 · Neurometrix, Inc. · Jan 2016
2-in-1 Abdominal Muscle Training & Back Pain Relief System
K152128 · Tohkai Precision Electrical Manufactory (Shenzhen) Limited · Dec 2015
Counter OTC TENS Device, Model CSD-737Z
K151279 · Counter Scientific Development (Gz), Ltd. · Dec 2015
PainKARE
K151034 · Triowave Technologies · Nov 2015
Tyece OTC TENS Device
K150386 · Tyece , Ltd. · Nov 2015