510(k) Report

FDA applicant

Migun Medical Instrument Co., Ltd.

Cleveland, OH2 decisions2003–20040 recalls

FDA records 2 decisions for Migun Medical Instrument Co., Ltd. (Cleveland, OH) from 2003 to 2004: 2 510(k) clearances. All are in product code JFB (Table, Physical Therapy, Multi Function). Its devices cite 2 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 Migun Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Migun Medical Instrument Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Migun Medical Instrument Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Migun Medical Instrument Co., Ltd.’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?

  • JFBTable, Physical Therapy, Multi Function2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K041200Thermassage Enegry Product, Model HY-7000Migun Medical Instrument Co., Ltd. · 20042cite it
  • K032449Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 20031cites it

What has FDA decided for it lately?

  • K041200Thermassage Enegry Product, Model HY-7000Migun Medical Instrument Co., Ltd. · 2004
  • K032449Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003

All 2 as Migun Medical Instrument Co., Ltd. →