Cleared Special

K122206 - GARAVENTA X3 INCLINED PLATFORM LIFT

K122206 is an FDA 510(k) clearance for GARAVENTA X3 INCLINED PLATFORM LIFT, manufactured by Garaventa (Canada) Ltd [Dba Garaventa Lift]. The device is a Class 2 Physical Medicine device with product code PCE cleared through the Special 510(k) pathway after a 239-day FDA review.

K122206 · Garaventa (Canada) Ltd [Dba Garaventa Lift] · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
239d
Days
Class 2
Risk

K122206 is an FDA 510(k) clearance for the GARAVENTA X3 INCLINED PLATFORM LIFT. Classified as Permanently Mounted Wheelchair Platform Lift (product code PCE), Class II - Special Controls.

Submitted by Garaventa (Canada) Ltd [Dba Garaventa Lift] (Roswell, US). The FDA issued a Cleared decision on March 21, 2013 after a review of 239 days - an extended review 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. Standard predicate reliance. 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 - K122206

510(k) Number K122206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date March 21, 2013
Days to Decision 239 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
123d slower than avg
Panel avg: 116d · This submission: 239d
Pathway characteristics
Modification to existing cleared device.

PCE Device Classification - Class 2, Special Controls

Product Code PCE Permanently Mounted Wheelchair Platform Lift
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3930
Definition Intended For Medical Purposes To Provide A Guided Platform To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another.
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.

K122206 · GARAVENTA X3 INCLINED PLATFORM LIFT
Download PDF FDA Summary Garaventa (Canada) Lt…