Cleared Traditional

K161537 - OTC TENS Device

K161537 is an FDA 510(k) clearance for OTC TENS Device, manufactured by Counter Scientific Development (Gz), Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K161537 · Counter Scientific Development (Gz), Ltd. · Neurology device
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Oct 2016
Decision
132d
Days
Class 2
Risk

K161537 is an FDA 510(k) clearance for the OTC TENS Device, Model PTS-IV. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Counter Scientific Development (Gz), Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 13, 2016 after a review of 132 days - within the typical 510(k) review window.

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 Counter Scientific Development (Gz), Ltd. devices

FDA 510(k) Submission Details - K161537

510(k) Number K161537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2016
Decision Date October 13, 2016
Days to Decision 132 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 148d · This submission: 132d
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 164
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K161537.
Smart Pain Reliever, Model LT5019
K162479 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2017
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K161453 · Well-Life Healthcare Limited · Dec 2016
Electronic Pulse Stimulator
K160508 · Beijing Choice Electronic Technololgy Co., Ltd. · Nov 2016
Heat Pain Pro
K160115 · Omron Healthcare, Inc. · Jun 2016
Quell
K152954 · Neurometrix, Inc. · Jan 2016
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K152852 · Bayer Healthcare, LLC · Dec 2015