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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K143551
Device Name Compex Wireless USA
Applicant
Djo, LLC
1430 Decision St.
Vista,  CA  92081 -8553
Applicant Contact GINA FLORES
Correspondent
Djo, LLC
1430 Decision St.
Vista,  CA  92081 -8553
Correspondent Contact GINA FLORES
Regulation Number890.5850
Classification Product Code
NGX  
Date Received12/15/2014
Decision Date 04/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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