510(k) Report

FDA applicant

Pdg Product Design Group, Inc.

Vancouver, Bc, CA8 decisions1996–20171 recall

FDA records 8 decisions for Pdg Product Design Group, Inc. (Vancouver, Bc, CA) from 1996 to 2017: 8 510(k) clearances. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Pdg Product Design Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12014: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pdg Product Design Group, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pdg Product Design Group, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IORWheelchair, Mechanical8decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063736Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 20074cite it
  • K990557The Stellar Tilt, Manually Operated WheelchairPdg Product Design Group, Inc. · 19992cite it
  • K961743Eclipse 600 Manually Operated WheelchairPdg Product Design Group, Inc. · 19961cites it
  • K971389Eclipse 400 Manually Operated WheelcairPdg Product Design Group, Inc. · 19971cites it

What has FDA decided for it lately?

  • K163432Stellar LEAPPdg Product Design Group, Inc. · 2017
  • K140023ElevationPdg Product Design Group, Inc. · 2014
  • K063736Fuze Mechanical Wheelchair, Models T20 and T50Pdg Product Design Group, Inc. · 20071 recall
  • K061475Astrotilt Manual WheelchairPdg Product Design Group, Inc. · 2006
  • K990557The Stellar Tilt, Manually Operated WheelchairPdg Product Design Group, Inc. · 1999
  • K971389Eclipse 400 Manually Operated WheelcairPdg Product Design Group, Inc. · 1997
  • K970311Bentley Manually Operated WheelchairPdg Product Design Group, Inc. · 1997
  • K961743Eclipse 600 Manually Operated WheelchairPdg Product Design Group, Inc. · 1996

All 8 as Pdg Product Design Group, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063736Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 JrJun 12, 2012Class II