Cleared Abbreviated

K121353 - MINI PATCH

K121353 is an FDA 510(k) clearance for MINI 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 126-day FDA review.

K121353 · Well-Life Healthcare Limited · Neurology device
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Sep 2012
Decision
126d
Days
Class 2
Risk

K121353 is an FDA 510(k) clearance for the MINI 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 September 7, 2012 after a review of 126 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 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 - K121353

510(k) Number K121353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2012
Decision Date September 07, 2012
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
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 K121353.
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