510(k) Report

FDA applicant

Activatek, Inc.

West Valley, UT3 decisions2006–20140 recalls

FDA records 3 decisions for Activatek, Inc. (West Valley, UT) from 2006 to 2014: 3 510(k) clearances. All are in product code EGJ (Device, Iontophoresis, Other Uses). Its devices cite 7 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2014

2009: 12014: 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 — Activatek, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Activatek, 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?

  • EGJDevice, Iontophoresis, Other Uses3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061522Trivarion Buffered Iontophoresis Electrode SystemActivatek, Inc. · 20062cite it

What has FDA decided for it lately?

  • K132832Activapatch ET Iontophoresis PatchActivatek, Inc. · 2014
  • K091326ActivapatchActivatek, Inc. · 2009
  • K061522Trivarion Buffered Iontophoresis Electrode SystemActivatek, Inc. · 2006

All 3 as Activatek, Inc. →