510(k) Report

FDA applicant

Bio-Feedback Systems, Inc.

Mchenry, IL11 decisions1977–19910 recalls

FDA records 11 decisions for Bio-Feedback Systems, Inc. (Mchenry, IL) from 1977 to 1991: 11 510(k) clearances. Most are in product codes HCC (Device, Biofeedback) and GWL (Amplifier, Physiological Signal). 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 Bio-Feedback Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Feedback Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio-Feedback Systems, 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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