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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
Type Traditional
Reviewed by Third Party No
Combination Product No
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