510(k) Report

FDA applicant

Naimco, Inc.

Chattanooga, TN3 decisions2004–20074 recalls

FDA records 3 decisions for Naimco, Inc. (Chattanooga, TN) from 2004 to 2007: 3 510(k) clearances. Most are in product codes IMG (Stimulator, Ultrasound And Muscle, For Use In…) and GXY (Electrode, Cutaneous). Its devices cite 9 predicates, 0 of them its own earlier devices. 4 recalls are 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 Naimco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

4in 2009

2009: 4
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Naimco, Inc.’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?

  • IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat1decision
  • GXYElectrode, Cutaneous1decision
  • EGJDevice, Iontophoresis, Other Uses1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K050469EZ-Stik ElectrodesNaimco, Inc. · 20053cite it
  • K040495Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405Naimco, Inc. · 20043cite it

What has FDA decided for it lately?

  • K063135Sonic-StimNaimco, Inc. · 2007
  • K050469EZ-Stik ElectrodesNaimco, Inc. · 20054 recalls
  • K040495Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405Naimco, Inc. · 2004

All 3 as Naimco, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K050469Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454…Nov 30, 2009Class II
  • K050469Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2&quot…Nov 30, 2009Class II
  • K050469Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and…Nov 30, 2009Class II
  • K050469Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2&quot…Nov 30, 2009Class II