510(k) Report

FDA applicant

Ergoline GmbH

Tuttlingen, Baden Wurttemberg, DE3 decisions2006–20220 recalls

FDA records 3 decisions for Ergoline GmbH (Tuttlingen, Baden Wurttemberg, DE) from 2006 to 2022: 3 510(k) clearances. Most are in product codes ISD (Exerciser, Measuring) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 3 predicates, 1 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 Ergoline GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ergoline GmbH 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?

  • ISDExerciser, Measuring2decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K212883ers2 - ergoline Rehabilitation SystemErgoline GmbH · 20221cites it
  • K053078Ergoselect 100 K/P, Ergoselect 200 K/PErgoline GmbH · 20061cites it

What has FDA decided for it lately?

  • K212883ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022
  • K112121Ergoselect/GEErgoline GmbH · 2012
  • K053078Ergoselect 100 K/P, Ergoselect 200 K/PErgoline GmbH · 2006

All 3 as Ergoline GmbH →