FDA applicant

Biotone International, Inc.

Mchenry, IL4 decisions1981–19820 recalls

FDA records 4 decisions for Biotone International, Inc. (Mchenry, IL) from 1981 to 1982: 4 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and EPF (Hearing Aid, Group And Auditory Trainer). 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 Biotone International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Biotone International, Inc.

Which product codes does it file in?

What has FDA decided for it lately?