FDA applicant

Nu Eyne Co., Ltd.

Seoul, KR5 decisions2019–20250 recalls

FDA records 5 decisions for Nu Eyne Co., Ltd. (Seoul, KR) from 2019 to 2025: 5 510(k) clearances. Most are in product codes PCC (Stimulator, Nerve, Electrical, Transcutaneous…) and QGL (Transcutaneous Nerve Stimulator For Adhd). Its devices cite 5 predicates, 2 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, neurology panel, where it files most

How often FDA has decided Nu Eyne Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Nu Eyne Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nu Eyne 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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Nu Eyne Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?