FDA 510(k) Application Details - K163201

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K163201
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	KWANG YANG MOTOR CO., LTD. No. 35, Wan Hsing Street, San Min Dist. Kaohsiung 803 TW Other 510(k) Applications for this Company
Contact	Wang Ching Yun 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	11/15/2016
Decision Date	03/16/2017
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