510(k) K051387

LEVO COMFORT II by Levo AG — Product Code IPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2005
Date Received
May 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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