510(k) Report

510(k) · Cleared

Cleared

Garaventa X3 Inclined Platform Lift

K122206510(k) SpecialCleared Mar 21, 2013239-day reviewClass II21 CFR 890.3930

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Garaventa (Canada) Ltd [Dba Garaventa Lift] · PCE Permanently Mounted Wheelchair Platform Lift

Cleared on Mar 21, 2013 as substantially equivalent to K981486 (Garaventa (Canada), Ltd., 1998) after a 239-day review. Its family tree reaches back 3 generations to 1989.

Decided
Mar 21, 2013
Review
239 days
Class
Class II
Product code
PCE
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K893544 (1989). No later device cites it as a predicate yet.

  1. Root · 3 generations backK893544 Handi Porch Elevator & Liberty Wheelchair LiftThe Cheney Co. · 1989
  2. 2 generations backK960276 Wheelchair ElevatorServices Industriels Savaria, Inc. · 1996
  3. 1 generation backK981486 Stair-LiftGaraventa (Canada), Ltd. · 1998
  4. This deviceK122206 Garaventa X3 Inclined Platform LiftGaraventa (Canada) Ltd [Dba Garaventa Lift] · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K893544Handi Porch Elevator & Liberty Wheelchair LiftThe Cheney Co.1989—
−2K960276Wheelchair ElevatorServices Industriels Savaria, Inc.1996—
−1K981486Stair-LiftGaraventa (Canada), Ltd.1998—
0 (this device)K122206Garaventa X3 Inclined Platform LiftGaraventa (Canada) Ltd [Dba Garaventa Lift]2013—
FIG. 1 — Lineage of K122206, 1989–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K981486Stair-Lift
Summary page 1
…5- Substantial equivalency is claimed against the following predicate device(s): 510k number Trade or Proprietary or Model Name Manufacturer K981486 STAIR-LIFT (Models GSL-1, GSL-2 & GSL-3) GARAVENTA (CANADA) LTD 6- Description of the device: *The Garaventa X3…
Garaventa (Canada), Ltd.1998—

Also cleared against K981486: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K981486.

How does its category compare?

All PCE devices

PCE Permanently Mounted Wheelchair Platform Lift: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PCE

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PCE

Too few PCE 510(k)s in any year since 2007 to give a median.

Recalls per year · PCE

No recall names PCE since 2007.

Adverse event reports per year · PCE

3in 2025

2016: 12017: 22022: 12023: 32024: 12025: 3
2007high 3 (2023) · low 0 (2007)2025

MAUDE reports naming product code PCE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—01
20170—02
20180—00
20190—00
20200—00
20210—00
20220—01
20230—03
20240—01
20250—03
20260—0—

What is it indicated for?

The Garaventa X3 inclined platform lift is intended to mechanically transport one person in a

wheelchair or in a fold-down seat up and down stairs in a private or public facility either

indoors or outdoors.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K122206: Garaventa X3 Inclined Platform Lift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122206

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026