510(k) Report

FDA applicant

Stoelting Co.

Wood Dale, IL4 decisions1995–20010 recalls

FDA records 4 decisions for Stoelting Co. (Wood Dale, IL) from 1995 to 2001: 4 510(k) clearances. All are in product code HCC (Device, Biofeedback). 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 Stoelting Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stoelting Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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