510(k) Report

FDA applicant

American Imex

Irvine, CA11 decisions1986–20040 recalls

FDA records 11 decisions for American Imex (Irvine, CA) from 1986 to 2004: 11 510(k) clearances. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 American Imex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Imex since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Imex 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 Relief11decisions

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.

  • K032003Premier PlusAmerican Imex · 20041cites it

What has FDA decided for it lately?

  • K032003Premier PlusAmerican Imex · 2004
  • K982221Premier APAmerican Imex · 1998
  • K926326Microcare (TM)American Imex · 1993
  • K912289Ultima XS, ModificationAmerican Imex · 1991
  • K895295Ultima XS Microcurrent TensAmerican Imex · 1989
  • K894388Zimmer TensAmerican Imex · 1989
  • K881704Easy TensAmerican Imex · 1988
  • K881424Premier 10S (Tens)American Imex · 1988

All 11 as American Imex →