510(k) Report

FDA applicant

Noraxon USA, Inc.

Scottsdale, AZ2 decisions1990–19900 recalls

FDA records 2 decisions for Noraxon USA, Inc. (Scottsdale, AZ) in 1990: 2 510(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 Noraxon USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Noraxon USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Noraxon USA, Inc. 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, Biofeedback2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K895635Myosystem 1000 ElectromyographNoraxon USA, Inc. · 19901cites it

What has FDA decided for it lately?

  • K895635Myosystem 1000 ElectromyographNoraxon USA, Inc. · 1990
  • K895633Myotrace 10 Biofeedback DeviceNoraxon USA, Inc. · 1990

All 2 as Noraxon USA, Inc. →