510(k) Report

FDA applicant

Wu'S Tech Co., Ltd.

Hsin-Chu City, TW24 decisions2002–20230 recalls

FDA records 24 decisions for Wu'S Tech Co., Ltd. (Hsin-Chu City, TW) from 2002 to 2023: 24 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 15 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Wu’S Tech Co., Ltd.”.

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 Wu'S Tech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 22008: 12009: 12019: 12020: 12023: 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wu'S Tech Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wu'S Tech Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report