510(k) Report

FDA applicant

Hasomed GmbH

Magdeburg, DE4 decisions2007–20170 recalls

FDA records 4 decisions for Hasomed GmbH (Magdeburg, DE) from 2007 to 2017: 4 510(k) clearances. All are in product code GZI (Stimulator, Neuromuscular, External Functional). Its devices cite 5 predicates, 4 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, neurology panel, where it files most

How often FDA has decided Hasomed GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12011: 12014: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hasomed GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hasomed GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GZIStimulator, Neuromuscular, External Functional4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K073237Rehastim & RehamoveHasomed GmbH · 20072cite it
  • K112844Rehastim 2, Rehamove 2Hasomed GmbH · 20112cite it
  • K132416Rehastim 2, Erigopro (Fes)Hasomed GmbH · 20141cites it

What has FDA decided for it lately?

  • K162683RehaStim 2Hasomed GmbH · 2017
  • K132416Rehastim 2, Erigopro (Fes)Hasomed GmbH · 2014
  • K112844Rehastim 2, Rehamove 2Hasomed GmbH · 2011
  • K073237Rehastim & RehamoveHasomed GmbH · 2007

All 4 as Hasomed GmbH →