FDA 510(k) Application Details - K211942

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K211942
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District Shenzhen 518116 CN Other 510(k) Applications for this Company
Contact	Li Yang 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	06/23/2021
Decision Date	12/13/2021
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