FDA 510(k) Application Details - K161974

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K161974
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Bio-Medical Research Ltd. Parkmore Business Park West Galway H91 NHT7 IE Other 510(k) Applications for this Company
Contact	Anne-Marie Keenan 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	07/18/2016
Decision Date	11/01/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review