FDA 510(k) Application Details - K181163

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K181163
Device Name	Wheelchair, Powered
Applicant	Wu's Tech Co., Ltd. No. 225, Yuan Peir St. Hsin-Chu City 30093 CN Other 510(k) Applications for this Company
Contact	Jen Ke-Min Other 510(k) Applications for this Contact
Regulation Number	890.3860   More FDA Info for this Regulation Number
Classification Product Code	ITI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2018
Decision Date	02/16/2019
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