FDA 510(k) Application Details - K231440

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K231440
Device Name	Stimulator, Muscle, Powered
Applicant	Shenzhen Roundwhale Technology Co., Ltd. 202,2/F,Building 27, Dafa Industrial Park, Longxi community, Longgang street, Longgang district Shenzhen 518108 CN Other 510(k) Applications for this Company
Contact	Zeng Chunming Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2023
Decision Date	11/03/2023
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