510(k) Report

FDA applicant

Zhejiang Qiangnao Technology Co.,Ltd

Hangzhou, CN2 decisions2022–20260 recalls

FDA records 2 decisions for Zhejiang Qiangnao Technology Co.,Ltd (Hangzhou, CN) from 2022 to 2026: 2 510(k) clearances. All are in product code GXY (Electrode, Cutaneous). Its devices cite 2 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 Zhejiang Qiangnao Technology Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Zhejiang Qiangnao Technology Co.,Ltd by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhejiang Qiangnao Technology 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, Cutaneous2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K220002Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 20222cite it

What has FDA decided for it lately?

  • K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd · 2026
  • K220002Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd · 2022

All 2 as Zhejiang Qiangnao Technology Co.,Ltd →