FDA applicant

Heelbo, Inc.

Libertyville, IL14 decisions1996–19980 recalls

FDA records 14 decisions for Heelbo, Inc. (Libertyville, IL) from 1996 to 1998: 14 510(k) clearances. All are in product code FMQ (Restraint, Protective). Its devices cite 2 predicates, 2 of them its own earlier devices. 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Heelbo, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Heelbo, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?