Cleared Abbreviated

K133723 - OTC PATCH

K133723 is an FDA 510(k) clearance for OTC PATCH, manufactured by Well-Life Healthcare Limited. The device is a Class 2 Neurology device with product code NUH cleared through the Abbreviated 510(k) pathway after a 53-day FDA review.

K133723 · Well-Life Healthcare Limited · Neurology device
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Jan 2014
Decision
53d
Days
Class 2
Risk

K133723 is an FDA 510(k) clearance for the OTC PATCH. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Yunghe City, Taipei County, TW). The FDA issued a Cleared decision on January 28, 2014 after a review of 53 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Well-Life Healthcare Limited devices

FDA 510(k) Submission Details - K133723

510(k) Number K133723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2013
Decision Date January 28, 2014
Days to Decision 53 days
Submission Type Abbreviated
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
95d faster than avg
Panel avg: 148d · This submission: 53d
Pathway characteristics
Standards-based clearance path.

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 163
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K133723.
OTC COMBO TENS/EMS SYSTEM
K141299 · Well-Life Healthcare Limited · Nov 2014
ASCEND
K140333 · Neurometrix, Inc. · Jul 2014
HIVOX ELECTRIC STIMULATOR OTC TENS
K140650 · Hivox Biotek, Inc. · Jun 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