510(k) Report

FDA applicant

Bio-Logic Devices

Deer Park, NY4 decisions1987–19880 recalls

FDA records 4 decisions for Bio-Logic Devices (Deer Park, NY) from 1987 to 1988: 4 510(k) clearances. Most are in product codes HCC (Device, Biofeedback) and IKN (Electromyograph, Diagnostic). 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-Logic Devices’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Logic Devices since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HCCDevice, Biofeedback3decisions
  • IKNElectromyograph, Diagnostic1decision

What has FDA decided for it lately?

  • K880914T824 Temperature MonitorBio-Logic Devices · 1988
  • K880913M424 Emg MonitorBio-Logic Devices · 1988
  • K880916M444 Emg MonitorBio-Logic Devices · 1988
  • K864660Model M402 Emg MonitorBio-Logic Devices · 1987

All 4 as Bio-Logic Devices →