FDA 510(k) Application Details - K222201

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K222201
Device Name	Stimulator, Muscle, Powered
Applicant	Medlander Medical Technology Inc. Building 5, Acceleration Zone, Nanjing Life Science and Technology, Innovation Park Nanjing 211100 CN Other 510(k) Applications for this Company
Contact	Wang Wang 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	07/25/2022
Decision Date	10/21/2022
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