510(k) Report

FDA applicant

Somedic AB

Sweden1 decision1984–19840 recalls

FDA records 1 decision for Somedic AB (Sweden) in 1984: 1 510(k) clearance. All are in product code LLN (Device, Vibration Threshold Measurement). 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 Somedic AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Somedic AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Somedic AB 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?

  • LLNDevice, Vibration Threshold Measurement1decision

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.

  • K843486VibrameterSomedic AB · 19842cite it

What has FDA decided for it lately?

  • K843486VibrameterSomedic AB · 1984

The one decision as Somedic AB →