FDA 510(k) Application Details - K162952

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K162952
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	CHIEN TI ENTERPRISE CO., LTD. NO. 13, LANE 227, FU YING RD NEW TAIPEI CITY, HSIN CHUANG DISTRICT 24258 TW Other 510(k) Applications for this Company
Contact	VIVIAN LO 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	10/24/2016
Decision Date	05/03/2017
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