FDA applicant

Gmdasz Manufacturing Co., Ltd.

Echo, OR2 decisions2009–20160 recalls

FDA records 2 decisions for Gmdasz Manufacturing Co., Ltd. (Echo, OR) from 2009 to 2016: 2 510(k) clearances. All are in product code GXY (Electrode, Cutaneous). Its devices cite 4 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, neurology panel, where it files most

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

FDA decisions per year

1in 2016

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Gmdasz Manufacturing Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gmdasz Manufacturing 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

Gmdasz Manufacturing 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?