FDA applicant

Foshan Gaunying Electronics Co., Ltd.

Bonita Springs, FL6 decisions2010–20140 recalls

FDA records 6 decisions for Foshan Gaunying Electronics Co., Ltd. (Bonita Springs, FL) from 2010 to 2014: 6 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 6 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 Foshan Gaunying Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2010high 2 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Foshan Gaunying Electronics Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Foshan Gaunying Electronics 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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Foshan Gaunying Electronics Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?