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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 STREET
VISTA,  CA  92081 -8553
Applicant Contact GINA FLORES
Correspondent
DJO, LLC
1430 DECISION STREET
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
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