Cleared Traditional

K161537 - OTC TENS Device, Model PTS-IV

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 149d · 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 Consultant

Media Trade Corporation
GUENTER GINSBERG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K161537.
CP Relief Wand-OTC
K162630 · Mid-America Medical Innovations, LLC · Dec 2016
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
Painmaster MCT Patch
K151995 · Newmark, Inc. · Oct 2016
HBOTC Muscle and Nerve Stimulator
K160255 · Hb Medical, Inc. · Sep 2016
HANAROCare ReJu
K160893 · M.I. Tech Co., Ltd. · Jul 2016