510(k) K202728

Action Trackchair Hawk by Action Manufacturing, Inc. — Product Code IPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2022
Date Received
September 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type