FDA applicant

Orthofab, Inc.

Quebec, Quebec, CA7 decisions1985–19970 recalls

FDA records 7 decisions for Orthofab, Inc. (Quebec, Quebec, CA) from 1985 to 1997: 7 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and IOR (Wheelchair, Mechanical). 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 Orthofab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthofab, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Orthofab, Inc.

Which product codes does it file in?

What has FDA decided for it lately?