Cleared Traditional

K113724 - ELECTROPULSE-COSMETIC

K113724 is an FDA 510(k) clearance for ELECTROPULSE-COSMETIC, manufactured by Pain Relief Technologies. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K113724 · Pain Relief Technologies · Neurology device
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Feb 2012
Decision
58d
Days
Class 2
Risk

K113724 is an FDA 510(k) clearance for the ELECTROPULSE-COSMETIC. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Pain Relief Technologies (Beaverton, US). The FDA issued a Cleared decision on February 15, 2012 after a review of 58 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K113724

510(k) Number K113724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date February 15, 2012
Days to Decision 58 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 149d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 80
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K113724.
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K103472 · Carol Cole Company · Nov 2011
K113724 · ELECTROPULSE-COSMETIC
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