FDA 510(k) Application Details - K130052

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K130052
Device Name	Stimulator, Muscle, Powered
Applicant	TONE-A-MATIC INTERNATIONAL, INC. 145 TRADERS BLVD, EAST, UNIT 18 MISSISSAUGA, ONTARIO L4Z-3L3 CA Other 510(k) Applications for this Company
Contact	ANNIA KORDIUK Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2013
Decision Date	12/20/2013
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