510(k) Report

FDA applicant

Xian Friendship Medical Electronics Co., Ltd.

Haidian Dis., Beijing, CN2 decisions2011–20120 recalls

FDA records 2 decisions for Xian Friendship Medical Electronics Co., Ltd. (Haidian Dis., Beijing, CN) from 2011 to 2012: 2 510(k) clearances. Most are in product codes ETN (Stimulator, Nerve) and GXY (Electrode, Cutaneous). Its devices cite 5 predicates, 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, ear, nose and throat panel, where it files most

How often FDA has decided Xian Friendship Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Xian Friendship Medical Electronics Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xian Friendship Medical Electronics…’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?

  • ETNStimulator, Nerve1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd. · 20121cites it
  • K110289Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 20111cites it

What has FDA decided for it lately?

  • K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd. · 2012
  • K110289Friendship Medical Disposable Pre-Gelled AG / Agcl Surface ElectrodeXian Friendship Medical Electronics Co., Ltd. · 2011

All 2 as Xian Friendship Medical Electronics Co., Ltd. →

Other applicant names beginning “Xian”

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

Xian Wingspan Electronic Technology Co., Ltd. 1Xian Friendship Electronics Co., Ltd. 1