Cleared Traditional

K041503 - HOVERJACK AIR PATIENT LIFT DEVICE

K041503 is an FDA 510(k) clearance for HOVERJACK AIR PATIENT LIFT DEVICE, manufactured by D.T. Davis Enterprises , Ltd.. The device is a Class 2 General Hospital device with product code FNG cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K041503 · D.T. Davis Enterprises , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
66d
Days
Class 2
Risk

K041503 is an FDA 510(k) clearance for the HOVERJACK AIR PATIENT LIFT DEVICE. Classified as Lift, Patient, Ac-powered (product code FNG), Class II - Special Controls.

Submitted by D.T. Davis Enterprises , Ltd. (Bethlehem, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041503

510(k) Number K041503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date August 12, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNG Device Classification - Class 2, Special Controls

Product Code FNG Lift, Patient, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FNG Lift, Patient, Ac-powered

All 18
Devices cleared under the same product code (FNG) and FDA review panel - the closest regulatory comparables to K041503.
HT-WEDGE
K121287 · D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · Oct 2012
PATIENT SUPPORT SYSTEM
K940872 · Arylift, Inc. · Oct 1994
A.C. POWER PATIENT LIFT
K935351 · Ken Kemmerer · Feb 1994
SAF-LIFT/SAF-KARY
K926411 · Arjo-Century, Inc. · Mar 1993
PATIENT LIFT AND TRANSPORT
K912769 · Century Manufacturing Co. · Oct 1991
MANGAR BOOSTER
K905414 · Northfleet Management Group, Inc. · Mar 1991
K041503 · HOVERJACK AIR PATIENT LIFT DEVICE
Download PDF FDA Summary D.T. Davis Enterprise…