510(k) Report

FDA applicant

Soleus Champ International Co., Ltd.

Hsin Chu City, TW1 decision2005–20050 recalls

FDA records 1 decision for Soleus Champ International Co., Ltd. (Hsin Chu City, TW) in 2005: 1 510(k) clearance. All are in product code 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 Soleus Champ International Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Soleus Champ International Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Soleus Champ International 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?

  • ITIWheelchair, Powered1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K043511Soleus Powered Wheelchair, Model Fad-2Soleus Champ International Co., Ltd. · 2005

The one decision as Soleus Champ International Co., Ltd. →