510(k) Report

FDA applicant

Top-Rank Health Care Equipment Co., Ltd.

Shangyu City, CN2 decisions2007–20130 recalls

FDA records 2 decisions for Top-Rank Health Care Equipment Co., Ltd. (Shangyu City, CN) from 2007 to 2013: 2 510(k) clearances. All are in product code GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 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 Top-Rank Health Care Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Top-Rank Health Care Equipment 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, Cutaneous2decisions

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K070612Top-Rank Adhesive ElectrodeTop-Rank Health Care Equipment Co., Ltd. · 20073cite it
  • K132588Adhesive ElectrodesTop-Rank Health Care Equipment Co., Ltd. · 20133cite it

What has FDA decided for it lately?

  • K132588Adhesive ElectrodesTop-Rank Health Care Equipment Co., Ltd. · 2013
  • K070612Top-Rank Adhesive ElectrodeTop-Rank Health Care Equipment Co., Ltd. · 2007

All 2 as Top-Rank Health Care Equipment Co., Ltd. →