510(k) K082857

RENEGADE WHEELCHAIR by Alpha One — Product Code IQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2009
Date Received
September 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Special Grade
Device Class
Class II
Regulation Number
890.3880
Review Panel
PM
Submission Type