FDA 510(k) Application Details - K241433

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K241433
Device Name	Stimulator, Muscle, Powered
Applicant	WEERO Co.,Ltd. A-605, Venture Valley II, 142-10, Saneop-Ro 156 Beon-Gil, Gwonseon-Gu Suwon-Si,Gyeonggi-Do Suwon 16648 KR Other 510(k) Applications for this Company
Contact	Moon young Han 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	05/21/2024
Decision Date	06/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review