Cleared Abbreviated

GENESIS VERTICAL PLATFORM LIFT (K033469) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K033469 · Garaventa Accessibility · Physical Medicine device
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Jan 2004
Decision
65d
Days
Class 2
Risk

K033469 is an FDA 510(k) clearance for the GENESIS VERTICAL PLATFORM LIFT. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by Garaventa Accessibility (Surrey, British Columbia, CA). The FDA issued a Cleared decision on January 7, 2004 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3930 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Garaventa Accessibility devices

Submission Details

510(k) Number K033469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2003
Decision Date January 07, 2004
Days to Decision 65 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code ING Elevator, Wheelchair, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3930
Definition A Motorized Lift Device That Is Not Permanently Mounted In One Location And That Is Intended For Medical Purposes To Provide A Means To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another (e.g., Portable Platform Lifts, Attendant-operated Stair Climbing Devices For Wheelchairs).
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 Physical Medicine devices follow this clearance model.