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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 K201653
Device Name Compex Sport Elite 3.0
Applicant
DJO, LLC
1430 Decision Street
Vista,  CA  92081
Applicant Contact Michael Davis
Correspondent
DJO, LLC
1430 Decision Street
Vista,  CA  92081
Correspondent Contact Michael Davis
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
NUH   NYN  
Date Received06/18/2020
Decision Date 11/27/2020
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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