510(k) K051709

HIPPOCAMPE WHEELCHAIR by Vipamat Technologie — Product Code IQC

K051709 is an FDA 510(k) premarket notification submitted by Vipamat Technologie for the device "HIPPOCAMPE WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on August 15, 2005. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
June 27, 2005
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