FDA 510(k) Application Details - K163451

Device Classification Name	Wheelchair, Standup   More FDA Info for this Device
510(K) Number	K163451
Device Name	Wheelchair, Standup
Applicant	Action Manufacturing Inc. 1105 Lake Rd. Marshall, MN 56258 US Other 510(k) Applications for this Company
Contact	Alan Macht Other 510(k) Applications for this Contact
Regulation Number	890.3900   More FDA Info for this Regulation Number
Classification Product Code	IPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2016
Decision Date	01/12/2018
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