FDA 510(k) Application Details - K211919

Device Classification Name	Components, Wheelchair   More FDA Info for this Device
510(K) Number	K211919
Device Name	Components, Wheelchair
Applicant	Kinetic Innovative Seating System LLC 26 N. Main Street, Office Bldg Branford, CT 06405 US Other 510(k) Applications for this Company
Contact	Susan Farricielli Other 510(k) Applications for this Contact
Regulation Number	890.3920   More FDA Info for this Regulation Number
Classification Product Code	KNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2021
Decision Date	03/04/2022
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