510(k) K121287

HT-WEDGE by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L — Product Code FNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2012
Date Received
April 30, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Ac-Powered
Device Class
Class II
Regulation Number
880.5500
Review Panel
HO
Submission Type