FDA 510(k) Application Details - K213748

Device Classification Name	Stimulator, Muscle, Powered, For Muscle Conditioning   More FDA Info for this Device
510(K) Number	K213748
Device Name	Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant	Lutronic Corporation Lutronic Center, 219, Sowon-Ro Deogyang-Gu, Goyang-si 410220 KR Other 510(k) Applications for this Company
Contact	Haewon Park 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	11/30/2021
Decision Date	10/14/2022
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