FDA 510(k) Application Details - K190699

Device Classification Name	Wheelchair, Mechanical   More FDA Info for this Device
510(K) Number	K190699
Device Name	Wheelchair, Mechanical
Applicant	Rowheels Inc. 8001 Terrace Ave, Ste 204 Middleton, WI 53562 US Other 510(k) Applications for this Company
Contact	Matthew Doeppers 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	03/18/2019
Decision Date	05/09/2019
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