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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K182581
Device Name PlayMakar Sport Muscle Stimulator, Model PRO-500
Applicant
Playmakar, Inc.
1603 Hart St.
Southlake,  TX  76092
Applicant Contact Mike Williams
Correspondent
Media Trade Corporation
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact Guenter Ginsberg
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received09/19/2018
Decision Date 11/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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