FDA 510(k) Application Details - K160323

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K160323
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	DK ELECTRONICS, LLC 413-B ELMWOOD AVE, SHARON HILL, PA 19079 US Other 510(k) Applications for this Company
Contact	AVERY HUFF Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	NGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2016
Decision Date	04/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review