FDA 510(k) Application Details - K191356

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K191356
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	PUC Perfect Union Co., LTD. 8F-4, No.20, Lane 609, Sec. 5, Chungshin Road Sanchung District New Taipei City 241 TW Other 510(k) Applications for this Company
Contact	Anita 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	05/21/2019
Decision Date	01/11/2022
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