510(k) Report

FDA applicant

Koalaty Products, Inc.

Tampa, FL3 decisions2007–20100 recalls

FDA records 3 decisions for Koalaty Products, Inc. (Tampa, FL) from 2007 to 2010: 3 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 4 predicates, 0 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 Koalaty Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Koalaty Products, Inc. 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?

  • IPFStimulator, Muscle, Powered2decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 20102cite it
  • K072795Models Ems 5.0, Ems 5.1Koalaty Products, Inc. · 20071cites it
  • K080661Models Tens 7000, Ems 7500 and Twin StimKoalaty Products, Inc. · 20081cites it

What has FDA decided for it lately?

  • K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
  • K080661Models Tens 7000, Ems 7500 and Twin StimKoalaty Products, Inc. · 2008
  • K072795Models Ems 5.0, Ems 5.1Koalaty Products, Inc. · 2007

All 3 as Koalaty Products, Inc. →