FDA 510(k) Application Details - K243763

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K243763
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Changsha Anxiang Medical Technology Co., Ltd. 9th Floor, R&D Center and Supporting Projects 101, No.18 Shaoshan Middle Road, Dongtang Street, Yuhua District Changsha 410000 CN Other 510(k) Applications for this Company
Contact	William Fu 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	12/06/2024
Decision Date	03/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review