510(k) Report

FDA applicant

Ems Dist.

Pen Valley, CA3 decisions1982–19930 recalls

FDA records 3 decisions for Ems Dist. (Pen Valley, CA) from 1982 to 1993: 3 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and IPF (Stimulator, Muscle, Powered). 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 Ems Dist.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ems Dist. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ems Dist. 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 Relief2decisions
  • IPFStimulator, Muscle, Powered1decision

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.

  • K931570Com-Tens (Single Mode)Ems Dist. · 19931cites it

What has FDA decided for it lately?

  • K931570Com-Tens (Single Mode)Ems Dist. · 1993
  • K921813Med-TensEms Dist. · 1992
  • K812984Slimtronics 2000Ems Dist. · 1982

All 3 as Ems Dist. →