FDA applicant

Bloomex International, Inc.

Mchenry, IL16 decisions1979–19950 recalls

FDA records 16 decisions for Bloomex International, Inc. (Mchenry, IL) from 1979 to 1995: 16 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and LEJ (Booth, Sun Tan). 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 Bloomex International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bloomex International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bloomex International, 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

Bloomex International, Inc.

Which product codes does it file in?

What has FDA decided for it lately?