FDA applicant

Health Systems Intl., Inc.

Gurnee, IL4 decisions1986–19890 recalls

FDA records 4 decisions for Health Systems Intl., Inc. (Gurnee, IL) from 1986 to 1989: 4 510(k) clearances. Most are in product codes LEJ (Booth, Sun Tan) and 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, general and plastic surgery panel, where it files most

How often FDA has decided Health Systems Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health Systems Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Health Systems Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?