510(k) Report

FDA applicant

Wandy Rubber Industrial Co., Ltd.

Shi-Chih, Taipei, TW4 decisions2001–20130 recalls

FDA records 4 decisions for Wandy Rubber Industrial Co., Ltd. (Shi-Chih, Taipei, TW) from 2001 to 2013: 4 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and DRX (Electrode, Electrocardiograph). Its devices cite 3 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 Wandy Rubber Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Wandy Rubber Industrial 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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Which product codes does it file in?

  • GXYElectrode, Cutaneous3decisions
  • DRXElectrode, Electrocardiograph1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K132998Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 20134cite it
  • K002219Wandy Self-Adhesive Neurostimulation ElectrodeWandy Rubber Industrial Co., Ltd. · 20012cite it
  • K002227Wandy Silicone Conductive Rubber PadWandy Rubber Industrial Co., Ltd. · 20011cites it

What has FDA decided for it lately?

  • K132998Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
  • K031174Body Signal Ecg ElectrodeWandy Rubber Industrial Co., Ltd. · 2003
  • K002227Wandy Silicone Conductive Rubber PadWandy Rubber Industrial Co., Ltd. · 2001
  • K002219Wandy Self-Adhesive Neurostimulation ElectrodeWandy Rubber Industrial Co., Ltd. · 2001

All 4 as Wandy Rubber Industrial Co., Ltd. →