Cleared Special

K020933 - GARAVENTA SUPER-TRAC TRE-52

K020933 is an FDA 510(k) clearance for GARAVENTA SUPER-TRAC TRE-52, manufactured by Garaventa Accessibility. The device is a Class 2 Physical Medicine device with product code ING cleared through the Special 510(k) pathway after a 13-day FDA review.

K020933 · Garaventa Accessibility · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
13d
Days
Class 2
Risk

K020933 is an FDA 510(k) clearance for the GARAVENTA SUPER-TRAC TRE-52. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by Garaventa Accessibility (Blain, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020933

510(k) Number K020933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2002
Decision Date April 04, 2002
Days to Decision 13 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 116d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

ING Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ING Elevator, Wheelchair, Portable

All 28
Devices cleared under the same product code (ING) and FDA review panel - the closest regulatory comparables to K020933.
BRUNO VERTICAL PLATFORM LIFT, MODEL VPL-3100
K061514 · Bruno Independent Living Aids, Inc. · Jul 2006
GENESIS VERTICAL PLATFORM LIFT
K033469 · Garaventa Accessibility · Jan 2004
THE MULTILIFT
K024346 · Services Industriels Savaria, Inc. · Mar 2003
VERTICAL LIFT
K983526 · Barnes,Richardson & Colburn · Dec 1998
STAIR-LIFT
K981486 · Garaventa (Canada) , Ltd. · Jul 1998
TRUSLIFT PORCH LIFT
K964134 · Trus T Lift · Dec 1996
K020933 · GARAVENTA SUPER-TRAC TRE-52
Download PDF FDA Summary Garaventa Accessibili…