510(k) Report

FDA applicant

Danmeter A/S

Odense C, DK4 decisions2003–20050 recalls

FDA records 4 decisions for Danmeter A/S (Odense C, DK) from 2003 to 2005: 4 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and KPI (Stimulator, Electrical, Non-Implantable, For…). 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, physical medicine panel, where it files most

How often FDA has decided Danmeter A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Danmeter A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Danmeter A/S 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?

  • IPFStimulator, Muscle, Powered2decisions
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence1decision
  • OLWIndex-Generating Electroencephalograph Software1decision

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 5 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.

  • K032954Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Danmeter A/S · 20043cite it
  • K032955Automove, Model AM800Danmeter A/S · 20031cites it
  • K032988Elpha 4 ContiDanmeter A/S · 20031cites it

What has FDA decided for it lately?

  • K042315Cerebral State Monitor - CSMDanmeter A/S · 2005
  • K032954Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Danmeter A/S · 2004
  • K032955Automove, Model AM800Danmeter A/S · 2003
  • K032988Elpha 4 ContiDanmeter A/S · 2003

All 4 as Danmeter A/S →