Cleared Traditional

K130114 - PAINMASTER MCT PATCH

K130114 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 90-day FDA review.

K130114 · Newmark, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
90d
Days
Class 2
Risk

K130114 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. (Alexandria, US). The FDA issued a Cleared decision on April 16, 2013 after a review of 90 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 Newmark, Inc. devices

FDA 510(k) Submission Details - K130114

510(k) Number K130114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2013
Decision Date April 16, 2013
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K130114.
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · Hivox Biotek, Inc. · Jun 2014
OTC PATCH
K133723 · Well-Life Healthcare Limited · Jan 2014
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K130802 · Shenzhen Dongdixin Technology Co., Ltd. · Sep 2013
MINI PATCH
K121353 · Well-Life Healthcare Limited · Sep 2012
HIVOX BIOTEK INC.
K112392 · Hivox Biotek, Inc. · Mar 2012
MODEL PM3030
K110068 · Omron Healthcare, Inc. · Dec 2011