510(k) Report

FDA applicant

Dan Med, Inc.

Denver, CO6 decisions1997–20021 recall

FDA records 6 decisions for Dan Med, Inc. (Denver, CO) from 1997 to 2002: 6 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 1 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 Dan Med, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dan Med, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • IPFStimulator, Muscle, Powered4decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence1decision

Who builds on its devices?

Later devices cite its devices 8 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.

  • K972997AM800 Automove Emg Triggered Electrical Muscle StimulationDan Med, Inc. · 19974cite it
  • K012885Neuromove NM900Dan Med, Inc. · 20012cite it
  • K964738Elpha 2000 ContiDan Med, Inc. · 19972cite it

What has FDA decided for it lately?

  • K013210TruwaveDan Med, Inc. · 2002
  • K012885Neuromove NM900Dan Med, Inc. · 2001
  • K010745EMS 3000Dan Med, Inc. · 2001
  • K991241IF8000Dan Med, Inc. · 19991 recall
  • K972997AM800 Automove Emg Triggered Electrical Muscle StimulationDan Med, Inc. · 1997
  • K964738Elpha 2000 ContiDan Med, Inc. · 1997

All 6 as Dan Med, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K991241IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular…Jan 25, 2009Class II