510(k) Report

FDA applicant

Staodyne, Inc.

Longmont, CO9 decisions1992–19950 recalls

FDA records 9 decisions for Staodyne, Inc. (Longmont, CO) from 1992 to 1995: 9 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Staodyne, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Staodyne, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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