FDA 510(k) Application Details - K243783

Device Classification Name	Wheelchair, Standup   More FDA Info for this Device
510(K) Number	K243783
Device Name	Wheelchair, Standup
Applicant	Shenzhen Zuowei Technology Co., Ltd. Floor 2nd, Building 7th, Yi Fenghua Innovation Industrial Pk Xinshi Subdistrict, Dalang Street, Longhua District Shenzhen CN Other 510(k) Applications for this Company
Contact	Xingping Long Other 510(k) Applications for this Contact
Regulation Number	890.3900   More FDA Info for this Regulation Number
Classification Product Code	IPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2024
Decision Date	03/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review