FDA 510(k) Application Details - K163165

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K163165
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 US Other 510(k) Applications for this Company
Contact	David Chmel 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	11/10/2016
Decision Date	02/16/2017
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