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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 K160323
Device Name FlowKeepers
Applicant
Dk Electronics, LLC
413-B Elmwood Ave.,
Sharon Hill,  PA  19079
Applicant Contact AVERY HUFF
Correspondent
Dk Electronics, LLC
413-B Elmwood Ave.,
Sharon Hill,  PA  19079
Correspondent Contact AVERY HUFF
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received02/05/2016
Decision Date 04/06/2017
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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