Cleared Traditional

K182581 - PlayMakar Sport Muscle Stimulator

K182581 is the FDA 510(k) clearance for PlayMakar Sport Muscle Stimulator by Playmakar, Inc.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K182581 · Playmakar, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Playmakar, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 148d · 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 Consultant

Media Trade Corporation
Guenter Ginsberg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K182581.
Maxpower Relief
K182120 · Omron Healthcare, Inc. · Jan 2019
Neck Care Therapy, Model: SYK 509B
K172897 · Shenzhen Osto Technology Co., Ltd. · Dec 2018
Low-frequency Multi-function physiotherapy instrument
K172837 · Shenzhen Osto Technology Co., Ltd. · Nov 2018
Heat Pain Pro
K181992 · Omron Healthcare, Inc. · Nov 2018
A6 OTC Pain Relief TENS
K182753 · Everyway Medical Instruments Co.,Ltd · Oct 2018
V2 OTC Pain Relief TENS
K182767 · Everyway Medical Instruments Co.,Ltd · Oct 2018