510(k) Report

FDA applicant

Theratech, Inc.

Great Neck, NY5 decisions2002–20060 recalls

FDA records 5 decisions for Theratech, Inc. (Great Neck, NY) from 2002 to 2006: 5 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and LIH (Interferential Current Therapy). Its devices cite 9 predicates, 2 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Theratech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Theratech, 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?

  • IPFStimulator, Muscle, Powered2decisions
  • LIHInterferential Current Therapy2decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K050847IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 20052cite it
  • K060975IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 20061cites it
  • K024100IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF and the Customer Private BrandTheratech, Inc. · 20031cites it
  • K021436Ttech Model 200E + Tens DeviceTheratech, Inc. · 20021cites it

What has FDA decided for it lately?

  • K060975IF True Sine Interferential Stimulator / Model WL-2206A1 & WI-2206A2Theratech, Inc. · 2006
  • K050847IF True Sine Interferential Stimulator, Model WL-2206ATheratech, Inc. · 2005
  • K024100IF Series True Sine Interferential Stimulator/Model: WL-2206, Well IF, Life IF and the Customer Private BrandTheratech, Inc. · 2003
  • K021436Ttech Model 200E + Tens DeviceTheratech, Inc. · 2002
  • K013768Powered Muscle StimulatorTheratech, Inc. · 2002

All 5 as Theratech, Inc. →