FDA 510(k) Application Details - K233035

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K233035
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Shenzhen Hengbosi Industrial Co., Ltd. 1035 Chuangke Building, No.72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District, Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Zhiwei Chen 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	09/25/2023
Decision Date	01/08/2024
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