Cleared Traditional

K182581 - PlayMakar Sport Muscle Stimulator, Model PRO-500 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182581 · Playmakar, Inc. · Neurology device
Nov 2018
Decision
63d
Days
Class 2
Risk

K182581 is an FDA 510(k) clearance for the PlayMakar Sport Muscle Stimulator, Model PRO-500. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Playmakar, Inc. (Southlake, US). The FDA issued a Cleared decision on November 21, 2018 after a review of 63 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.

Submission Details

510(k) Number K182581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2018
Decision Date November 21, 2018
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 163d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K182581.
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