FDA 510(k) Application Details - K232181

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K232181
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Hebei JT Medical Co., Ltd. C12 Hegu Industrial Park, Chaoyang Road, Development Zone ZhuoZhou city Baoding 072750 CN Other 510(k) Applications for this Company
Contact	Karen Liu 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	07/24/2023
Decision Date	04/24/2024
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