FDA 510(k) Application Details - K203806

Device Classification Name	Wheelchair, Powered   More FDA Info for this Device
510(K) Number	K203806
Device Name	Wheelchair, Powered
Applicant	Yamaha Motor CO., LTD. 2500 Shingai Iwata 438-8501 JP Other 510(k) Applications for this Company
Contact	Michiyo Yamazaki 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	12/28/2020
Decision Date	05/21/2021
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