510(k) Report

FDA applicant

Enraf-Nonius, B.V.

Rotterdam, NL5 decisions2003–20250 recalls

FDA records 5 decisions for Enraf-Nonius, B.V. (Rotterdam, NL) from 2003 to 2025: 5 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and IPF (Stimulator, Muscle, Powered). Its devices cite 5 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 Enraf-Nonius, B.V.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2015: 12023: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Enraf-Nonius, B.V. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Enraf-Nonius, B.V.’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?

  • GXYElectrode, Cutaneous1decision
  • IPFStimulator, Muscle, Powered1decision
  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat1decision
  • ITHEquipment, Traction, Powered1decision
  • IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K230472Sonopuls 190Enraf-Nonius, B.V. · 20231cites it
  • K151640Eltrac 471Enraf-Nonius, B.V. · 20151cites it

What has FDA decided for it lately?

  • K251083Compact IIEnraf-Nonius, B.V. · 2025
  • K243112Curapuls 670Enraf-Nonius, B.V. · 2025
  • K230472Sonopuls 190Enraf-Nonius, B.V. · 2023
  • K151640Eltrac 471Enraf-Nonius, B.V. · 2015
  • K030297Flexible Rubber Electrodes, Models: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130Enraf-Nonius, B.V. · 2003

All 5 as Enraf-Nonius, B.V. →