510(k) Report

FDA applicant

Timewaver Production GmbH

Kraenzlin, DE2 decisions2019–20210 recalls

FDA records 2 decisions for Timewaver Production GmbH (Kraenzlin, DE) from 2019 to 2021: 2 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and NUH (Stimulator, Nerve, Transcutaneous…). 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 Timewaver Production GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Timewaver Production GmbH by year, 2019–2026Sources: 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, Powered1decision
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

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 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.

  • K212832TimeWaver FrequencyTimewaver Production GmbH · 20211cites it

What has FDA decided for it lately?

  • K212832TimeWaver FrequencyTimewaver Production GmbH · 2021
  • K191075HealyTimewaver Production GmbH · 2019

All 2 as Timewaver Production GmbH →