510(k) Report

FDA applicant

Everlife Medical Instrument Co., Ltd.

Hsin Chu City, TW1 decision2005–20050 recalls

FDA records 1 decision for Everlife Medical Instrument Co., Ltd. (Hsin Chu City, TW) in 2005: 1 510(k) clearance. All are in product code GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 0 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 Everlife Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Everlife Medical Instrument Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050788EverlifeEverlife Medical Instrument Co., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K050788EverlifeEverlife Medical Instrument Co., Ltd. · 2005

The one decision as Everlife Medical Instrument Co., Ltd. →

Other applicant names beginning “Everlife”

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

Everlife Medical Equipment Co., Ltd. 3