510(k) Report

FDA applicant

Kwang Yang Motor Co., Ltd.

Banqiao, TW7 decisions2007–20170 recalls

FDA records 7 decisions for Kwang Yang Motor Co., Ltd. (Banqiao, TW) from 2007 to 2017: 7 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 10 predicates, 5 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 Kwang Yang Motor Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 22008: 32013: 12017: 1
2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kwang Yang Motor Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kwang Yang Motor Co., Ltd.’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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Other applicant names beginning “Kwang”

FDA records each applicant name separately; these may or may not be the same firm.