510(k) Report

FDA applicant

Wr Medical Electronics Co.

Stillwater, MN6 decisions1990–20100 recalls

FDA records 6 decisions for Wr Medical Electronics Co. (Stillwater, MN) from 1990 to 2010: 6 510(k) clearances. Most are in product codes ETN (Stimulator, Nerve) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). Its devices cite 6 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 Wr Medical Electronics Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 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 — Wr Medical Electronics Co. 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?

  • ETNStimulator, Nerve2decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)1decision
  • EGJDevice, Iontophoresis, Other Uses1decision
  • LLNDevice, Vibration Threshold Measurement1decision
  • KTBDevice, Iontophoresis, Specific Uses1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K910624Case IV Computer Aided Sensory Evaluator Version 4Wr Medical Electronics Co. · 19921cites it
  • K895838Brackmann Emg Monitoring SystemWr Medical Electronics Co. · 19901cites it
  • K063560Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 20071cites it

What has FDA decided for it lately?

  • K092809HRV AcquireWr Medical Electronics Co. · 2010
  • K063560Hilger Dual-Stim Nerve StimulatorWr Medical Electronics Co. · 2007
  • K000574Iontophoretic Drug Delivery Electrode, Iontophoretic Electrode (Active)Wr Medical Electronics Co. · 2000
  • K992874Q-Sweat Quantitative Sweat Measurement SystemWr Medical Electronics Co. · 1999
  • K910624Case IV Computer Aided Sensory Evaluator Version 4Wr Medical Electronics Co. · 1992
  • K895838Brackmann Emg Monitoring SystemWr Medical Electronics Co. · 1990

All 6 as Wr Medical Electronics Co. →