510(k) Report

FDA applicant

Gendron, Inc.

Archbold, OH1 decision2000–20000 recalls

FDA records 1 decision for Gendron, Inc. (Archbold, OH) in 2000: 1 510(k) clearance. All are in product code ITI (Wheelchair, Powered). No 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 Gendron, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gendron, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gendron, 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?

  • ITIWheelchair, Powered1decision

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.

  • K001923Regency Power Wheelchair, Model 7200, 7500 & 7800Gendron, Inc. · 20001cites it

What has FDA decided for it lately?

  • K001923Regency Power Wheelchair, Model 7200, 7500 & 7800Gendron, Inc. · 2000

The one decision as Gendron, Inc. →