FDA 510(k) Application Details - K242975

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K242975
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	Wuyi Aichi Industry & Trade Co., Ltd. Yongwu Road, Southeast Industrial Zone Wuyi City 321200 CN Other 510(k) Applications for this Company
Contact	Wei Lyu Other 510(k) Applications for this Contact
Regulation Number	890.3800   More FDA Info for this Regulation Number
Classification Product Code	INI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	05/07/2025
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