510(k) Report

FDA applicant

Bmr Ent., Inc.

Ireland, IR2 decisions1993–19930 recalls

FDA records 2 decisions for Bmr Ent., Inc. (Ireland, IR) in 1993: 2 510(k) clearances. All are in product code IPF (Stimulator, Muscle, 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 Bmr Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bmr Ent., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bmr Ent., Inc.’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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