510(k) Report

FDA applicant

Home Health Technology Co., Ltd.

Hsin Chu City, TW2 decisions2005–20050 recalls

FDA records 2 decisions for Home Health Technology Co., Ltd. (Hsin Chu City, TW) in 2005: 2 510(k) clearances. All are in product code ITI (Wheelchair, Powered). 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 Home Health Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Home Health Technology Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Home Health Technology 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, Powered2decisions

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K042719Home Health Power Wheelchair, Model HC-200Home Health Technology Co., Ltd. · 2005
  • K043376Home Health Power Wheelchair, Model HC-200TRHome Health Technology Co., Ltd. · 2005

All 2 as Home Health Technology Co., Ltd. →