FDA applicant

Electone, Inc.

Longwood, FL73 decisions1981–19970 recalls

FDA records 73 decisions for Electone, Inc. (Longwood, FL) from 1981 to 1997: 73 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and LRB (Face Plate Hearing Aid). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Electone, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Electone, Inc.

Which product codes does it file in?

What has FDA decided for it lately?