510(k) K041503

HOVERJACK AIR PATIENT LIFT DEVICE by D.T. Davis Enterprises , Ltd. — Product Code FNG

K041503 is an FDA 510(k) premarket notification submitted by D.T. Davis Enterprises , Ltd. for the device "HOVERJACK AIR PATIENT LIFT DEVICE". The FDA issued a decision of Substantially Equivalent on August 12, 2004. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2004
Date Received
June 7, 2004
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