510(k) Report

FDA applicant

Orthomedics

Mchenry, IL16 decisions1980–19830 recalls

FDA records 16 decisions for Orthomedics (Mchenry, IL) from 1980 to 1983: 16 510(k) clearances. Most are in product codes IQI (Orthosis, Limb Brace) and IQF (Orthosis, Cervical-Thoracic, Rigid). 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 Orthomedics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orthomedics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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