FDA 510(k) Application Details - K232198

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K232198
Device Name	Wheelchair, Mechanical
Applicant	Zhenjiang Assure Medical Equipment Co., Ltd. NO.297, Chuqiao Road Zhenjiang CN Other 510(k) Applications for this Company
Contact	Ying Mei Other 510(k) Applications for this Contact
Regulation Number	890.3850   More FDA Info for this Regulation Number
Classification Product Code	IOR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2023
Decision Date	09/15/2023
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