510(k) Report

FDA applicant

C.T.M. Homecare Product, Inc.

Eugene, OR14 decisions2002–20111 recall

FDA records 14 decisions for C.T.M. Homecare Product, Inc. (Eugene, OR) from 2002 to 2011: 14 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 15 predicates, 5 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 C.T.M. Homecare Product, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 32008: 12009: 22011: 2
2007high 3 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — C.T.M. Homecare Product, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C.T.M. Homecare Product, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • INIVehicle, Motorized 3-Wheeled11decisions
  • ITIWheelchair, Powered3decisions

Whose devices does it build on?

Its devices cite 15 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K031272C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 20032cite it
  • K070603C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 20071cites it
  • K073686C.T.M. Power Chair, Model HS-1500C.T.M. Homecare Product, Inc. · 20081cites it
  • K032919C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 20031cites it
  • K030387C.T.M. Mobility Scooter, Model HS-890C.T.M. Homecare Product, Inc. · 20031cites it
  • K032918C.T.M. Mobility Scooter, Model HS-235C.T.M. Homecare Product, Inc. · 20031cites it

What has FDA decided for it lately?

  • K110567C.T.M. Mobility Scooter HS515(3W)C.T.M. Homecare Product, Inc. · 2011
  • K110395C.T.M. Mobility Scooter - Model HS 118C.T.M. Homecare Product, Inc. · 2011
  • K091418C.T.M. Mobility Scooter, Model HS-628, Invacare OrionC.T.M. Homecare Product, Inc. · 2009
  • K090735C.T.M. Mobility Scooter, HS-528C.T.M. Homecare Product, Inc. · 20091 recall
  • K073686C.T.M. Power Chair, Model HS-1500C.T.M. Homecare Product, Inc. · 2008
  • K070602C.T.M. Mobility Scooter# HS-265C.T.M. Homecare Product, Inc. · 2007
  • K070603C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
  • K070025C.T.M. Mobility Scooter, Model HS-310C.T.M. Homecare Product, Inc. · 2007

All 14 as C.T.M. Homecare Product, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090735Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor…Dec 7, 2011