FDA 510(k) Application Details - K212090

Device Classification Name	Vehicle, Motorized 3-Wheeled   More FDA Info for this Device
510(K) Number	K212090
Device Name	Vehicle, Motorized 3-Wheeled
Applicant	Anhui JBH Medical Apparatus Co.,Ltd No.116 Qicang Road, Industrial park Chuzhou 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	07/06/2021
Decision Date	04/22/2022
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