510(k) Report

FDA applicant

Selectivemed Components, Inc.

Mount Vernon, OH7 decisions1995–20131 recall

FDA records 7 decisions for Selectivemed Components, Inc. (Mount Vernon, OH) from 1995 to 2013: 7 510(k) clearances. Most are in product codes EGJ (Device, Iontophoresis, Other Uses) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 13 predicates, 2 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Selectivemed Components, 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?

  • EGJDevice, Iontophoresis, Other Uses3decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions
  • IPFStimulator, Muscle, Powered1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K945676Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 19952cite it
  • K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40…Selectivemed Components, Inc. · 20032cite it
  • K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 20092cite it
  • K993081IO-DriveSelectivemed Components, Inc. · 20001cites it

What has FDA decided for it lately?

  • K120922Guardian Dysphagia Dual Channel Nmes UnitSelectivemed Components, Inc. · 2013
  • K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
  • K031053Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40…Selectivemed Components, Inc. · 20031 recall
  • K020476Medion 6000Selectivemed Components, Inc. · 2002
  • K993081IO-DriveSelectivemed Components, Inc. · 2000
  • K946230Endura Reusable Tens and Nmes ElectrodesSelectivemed Components, Inc. · 1995
  • K945676Guardian Disposable Tens and Tens/Nmes ElectrodesSelectivemed Components, Inc. · 1995

All 7 as Selectivemed Components, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K031053Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product…Mar 15, 2005