FDA 510(k) Application Details - K142976

Device Classification Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat   More FDA Info for this Device
510(K) Number	K142976
Device Name	Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant	Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, XiLiBaimang Industrial Estate Nanshan District Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Qilian Liu Other 510(k) Applications for this Contact
Regulation Number	890.5300   More FDA Info for this Regulation Number
Classification Product Code	IMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2014
Decision Date	08/26/2015
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