FDA 510(k) Application Details - K120217

Device Classification Name	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K120217
Device Name	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant	SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE SHENZHEN 518108 CN Other 510(k) Applications for this Company
Contact	KANG JIAN PING 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	01/24/2012
Decision Date	11/21/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review