FDA 510(k) Application Details - K182411

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K182411
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	Yongkang Dingchang Industry & Trade Co., LTD. No99, HuaxiRoad, Xicheng Street Yongkang 321300 CN Other 510(k) Applications for this Company
Contact	Cheng Chen 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	09/04/2018
Decision Date	06/24/2019
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