510(k) Report

FDA applicant

Empi

Arden Hills, MN60 decisions1977–20101 recall

FDA records 60 decisions for Empi (Arden Hills, MN) from 1977 to 2010: 60 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and EGJ (Device, Iontophoresis, Other Uses). Its devices cite 60 predicates, 39 of them its own earlier devices. 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, neurology panel, where it files most

How often FDA has decided Empi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 32009: 12010: 1
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Empi 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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief17decisions
  • EGJDevice, Iontophoresis, Other Uses11decisions
  • GXYElectrode, Cutaneous10decisions
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence8decisions
  • IPFStimulator, Muscle, Powered8decisions
  • HIRPerineometer2decisions

Also: GZI (1), LIH (1), BXB (1), KGX (1).

Whose devices does it build on?

Its devices cite 60 predicates; 39 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 82 times; 39 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.

  • K021100300 PV Complete Electrotherapy SystemEmpi · 200210cite it
  • K983484Dupel B.L.U.E. Small Iontophoresis ElectrodeEmpi · 19988cite it
  • K061650Select Tens, Model 4600SEmpi · 20077cite it
  • K951951Focus Model 795 UnitEmpi · 19966cite it
  • K970203Epix VTEmpi · 19975cite it
  • K912015TBD, Empi Buffered Iontophoresis Electroded MDL. 3Empi · 19914cite it

What has FDA decided for it lately?

  • K093324Empi ContinuumEmpi · 2010
  • K090922Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
  • K072946Hybresis Iontophoresis Drug Delivery SystemEmpi · 2007
  • K070427Dupel Transport Iontophoresis SystemEmpi · 2007
  • K061650Select Tens, Model 4600SEmpi · 2007
  • K041920Infinity Plus Electrotherapy SystemEmpi · 2005
  • K042057Infinity Electrotherapy SystemEmpi · 2004
  • K030395Empi Action Patch Iontophoresis SystemEmpi · 2003

All 60 as Empi →

What has been recalled?

1 recall linked to its devices; the latest:

  • K902195Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A…Feb 9, 2012Class II