FDA 510(k) Application Details - K201196

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K201196
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	Nanjing Jin Bai He Medical Apparatus Co., Ltd No. 12, Wuge Rd, Jiangning Nanjing 210000 CN Other 510(k) Applications for this Company
Contact	Dandan Yang 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	05/04/2020
Decision Date	06/25/2021
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