FDA 510(k) Application Details - K200135

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K200135
Device Name	Wheelchair, Mechanical
Applicant	RGK Wheelchairs, Ltd. Units 8 B/C Ring RD 2 Burntwood Business Park Burntwood WS7 3JQ GB Other 510(k) Applications for this Company
Contact	Devin McElroy 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	01/21/2020
Decision Date	09/10/2020
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