FDA 510(k) Application Details - K063728

Device Classification Name	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K063728
Device Name	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant	ALFA TECH MEDICAL SYSTEMS, LTD. 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	890.5860   More FDA Info for this Regulation Number
Classification Product Code	IMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2006
Decision Date	04/04/2007
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