FDA 510(k) Application Details - K232409

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K232409
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Shanghai Apolo Medical Technology Co., Ltd. Building 11, Lane 1566, Nanle Road, Songjiang District Shanghai 201613 CN Other 510(k) Applications for this Company
Contact	Felix 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	08/10/2023
Decision Date	04/10/2024
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