FDA 510(k) Application Details - K250027

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K250027
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	Intradin (Shanghai) Machinery Co., Ltd No. 118, Duhui Road, Minhang District Shanghai Shanghai CN Other 510(k) Applications for this Company
Contact	Mark Li 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	01/06/2025
Decision Date	02/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review