510(k) Report

FDA applicant

Global Fabtech Wheelchair (Shanghai) Co., Ltd.

Taichung, TW4 decisions2007–20100 recalls

FDA records 4 decisions for Global Fabtech Wheelchair (Shanghai) Co., Ltd. (Taichung, TW) from 2007 to 2010: 4 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Its devices cite 5 predicates, 1 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 Global Fabtech Wheelchair (Shanghai) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2010

2007: 12010: 3
2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Global Fabtech Wheelchair (Shanghai) Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Global Fabtech Wheelchair (Shanghai)…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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