510(k) Report

FDA applicant

Biomedical Design Instruments

Los Angeles, CA3 decisions1983–19900 recalls

FDA records 3 decisions for Biomedical Design Instruments (Los Angeles, CA) from 1983 to 1990: 3 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) 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, physical medicine panel, where it files most

How often FDA has decided Biomedical Design Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biomedical Design Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biomedical Design Instruments 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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • IKNElectromyograph, Diagnostic1decision
  • IPFStimulator, Muscle, Powered1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K883911Electro-Acuscope 85Biomedical Design Instruments · 19903cite it

What has FDA decided for it lately?

  • K883911Electro-Acuscope 85Biomedical Design Instruments · 1990
  • K833928MyopulseBiomedical Design Instruments · 1984
  • K833927Electro-Myoscope 85Biomedical Design Instruments · 1983

All 3 as Biomedical Design Instruments →