FDA 510(k) Application Details - K011880

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K011880
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	COMPEX S.A. 1225 EYE STREET, N.W. WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	ANSIS M HELMANIS 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	06/15/2001
Decision Date	04/17/2002
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