FDA 510(k) Application Details - K133638

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K133638
Device Name	Stimulator, Muscle, Powered
Applicant	FIRSTKIND LIMITED 231 FAIRBANKS STREET WEST BOYLSTON, MA 01583 US Other 510(k) Applications for this Company
Contact	SHEILA HEMEON-HEYER 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	11/27/2013
Decision Date	08/21/2014
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