510(k) Report

FDA applicant

Department of Medical Physics and Biomedical Eng.

Cleveland, OH1 decision2005–20050 recalls

FDA records 1 decision for Department of Medical Physics and Biomedical Eng. (Cleveland, OH) in 2005: 1 510(k) clearance. All are in product code GZI (Stimulator, Neuromuscular, External Functional). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Department of Medical Physics and Biomedical Eng.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Department of Medical Physics and Biomedical Eng. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Department of Medical Physics and Biomedical Eng. 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?

  • GZIStimulator, Neuromuscular, External Functional1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K050991The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 20053cite it

What has FDA decided for it lately?

  • K050991The Odfs Dropped Foot StimulatorDepartment of Medical Physics and Biomedical Eng. · 2005

The one decision as Department of Medical Physics and Biomedical Eng. →