Cleared Traditional

K151995 - Painmaster MCT Patch

K151995 is an FDA 510(k) clearance for Painmaster MCT Patch, manufactured by Newmark, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K151995 · Newmark, Inc. · Neurology device
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Oct 2016
Decision
443d
Days
Class 2
Risk

K151995 is an FDA 510(k) clearance for the Painmaster MCT Patch. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Newmark, Inc. (Cheshire, US). The FDA issued a Cleared decision on October 5, 2016 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Newmark, Inc. devices

FDA 510(k) Submission Details - K151995

510(k) Number K151995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date October 05, 2016
Days to Decision 443 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
295d slower than avg
Panel avg: 148d · This submission: 443d
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 K151995.
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