510(k) Report

FDA applicant

Valentine Intl., Ltd.

New Taipei City, TW2 decisions1995–20140 recalls

FDA records 2 decisions for Valentine Intl., Ltd. (New Taipei City, TW) from 1995 to 2014: 2 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and FOX (Stand, Infusion). 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 Valentine Intl., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Valentine Intl., Ltd. 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?

  • IORWheelchair, Mechanical1decision
  • FOXStand, Infusion1decision

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 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.

  • K130017Valentine Steel WheelchairValentine Intl., Ltd. · 20143cite it

What has FDA decided for it lately?

  • K130017Valentine Steel WheelchairValentine Intl., Ltd. · 2014
  • K952196IV Pole/StandValentine Intl., Ltd. · 1995

All 2 as Valentine Intl., Ltd. →