FDA 510(k) Application Details - K212948

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K212948
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Guangzhou Xinbo Electronic Co., Ltd. No.23 Building, The Second Phase, Huachuang Animation Industry Park, Panyu Guangzhou 511450 CN Other 510(k) Applications for this Company
Contact	Sammy Li 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	09/16/2021
Decision Date	11/01/2021
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