510(k) Report

FDA applicant

Lsi Intl., Inc.

Overland Park, KS5 decisions1994–20000 recalls

FDA records 5 decisions for Lsi Intl., Inc. (Overland Park, KS) from 1994 to 2000: 5 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 1 predicate, 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 Lsi Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lsi Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lsi Intl., 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, Powered3decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • JFBTable, Physical Therapy, Multi Function1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K002390Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 20002cite it

What has FDA decided for it lately?

  • K002390Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
  • K984021MS300Lsi Intl., Inc. · 1999
  • K984113MS400Lsi Intl., Inc. · 1999
  • K970696S.P. 100Lsi Intl., Inc. · 1997
  • K933653MS 2500Lsi Intl., Inc. · 1994

All 5 as Lsi Intl., Inc. →