510(k) Report

FDA applicant

Sterne Equipment Co., Ltd.

Brampton, On., CA6 decisions1989–20010 recalls

FDA records 6 decisions for Sterne Equipment Co., Ltd. (Brampton, On., CA) from 1989 to 2001: 6 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and IZL (System, X-Ray, Mobile). 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 Sterne Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterne Equipment Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sterne Equipment Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Sterne”

FDA records each applicant name separately; these may or may not be the same firm.