FDA 510(k) Application Details - K122414

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K122414
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	LETO ENTERPRISES INCORPORATION SUITE A-2706, ZHONGFANG JINGYUAN XINWEN ROAD, FUTIAN DISTRICT SHENZHEN 518100 CN Other 510(k) Applications for this Company
Contact	SABRINA WEI 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	08/08/2012
Decision Date	12/21/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review