510(k) Report

FDA applicant

Tarsys Engineering, Inc.

M4a 1c9, CA2 decisions1991–19911 recall

FDA records 2 decisions for Tarsys Engineering, Inc. (M4a 1c9, CA) in 1991: 2 510(k) clearances. All are in product code ITI (Wheelchair, Powered). 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 Tarsys Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tarsys Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ITIWheelchair, Powered2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K911151Power Wheelchair - Tilt & Recline Seating SystemTarsys Engineering, Inc. · 19911cites it

What has FDA decided for it lately?

  • K911151Power Wheelchair - Tilt & Recline Seating SystemTarsys Engineering, Inc. · 19911 recall
  • K911152Quad-Link Retractable MountTarsys Engineering, Inc. · 1991

All 2 as Tarsys Engineering, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K911151Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.Mar 10, 2003