510(k) Report

FDA applicant

Taiwan King Strong Co., Ltd.

Hsin Chu City, TW4 decisions2003–20040 recalls

FDA records 4 decisions for Taiwan King Strong Co., Ltd. (Hsin Chu City, TW) from 2003 to 2004: 4 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and ITI (Wheelchair, Powered). 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 Taiwan King Strong Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Taiwan King Strong Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Taiwan King Strong Co., 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, Mechanical2decisions
  • ITIWheelchair, Powered2decisions

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 1 time; 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.

  • K033100Taiwan King Strong Powered Wheelchair, TP 01Taiwan King Strong Co., Ltd. · 20031cites it

What has FDA decided for it lately?

  • K042652Taiwan King Strong TC 04 MechanicalwheelchairTaiwan King Strong Co., Ltd. · 2004
  • K033031Taiwan King Strong TC 03 Mechanical WheelchairTaiwan King Strong Co., Ltd. · 2003
  • K033100Taiwan King Strong Powered Wheelchair, TP 01Taiwan King Strong Co., Ltd. · 2003
  • K033097Taiwan King Strong Powered Wheelchair, TP 02Taiwan King Strong Co., Ltd. · 2003

All 4 as Taiwan King Strong Co., Ltd. →