510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K182581Substantially Equivalent

PlayMakar Sport Muscle Stimulator, Model PRO-500

Playmakar, Inc., Southlake TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K182581 is the FDA 510(k) clearance record for PlayMakar Sport Muscle Stimulator, Model PRO-500, a class II device, cleared for Playmakar, Inc. on under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter). FDA's definition for product code NUH reads: "TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES". FDA records list one 510(k) clearance for Playmakar, Inc. As of , FDA records show no recalls naming K182581.

Clearance record

Decision date
Received
(63 days to decision)
Product code
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Playmakar, Inc. 1603 Hart St., Southlake TX
510(k) summary
Statement
Third party review
No

Clearances, product code NUH

Trailing 12 months
10 clearances under product code NUH in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NUH, trailing twelve months
MonthClearances
November 20253
December 20253
January 20260
February 20260
March 20261
April 20260
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260