510(k) Report

FDA applicant

Guangzhou Finecure Medical Equipment Co.,Ltd

Shenzhen, CN3 decisions2013–20150 recalls

FDA records 3 decisions for Guangzhou Finecure Medical Equipment Co.,Ltd (Shenzhen, CN) from 2013 to 2015: 3 510(k) clearances. Most are in product codes KPI (Stimulator, Electrical, Non-Implantable, For…) and IPF (Stimulator, Muscle, Powered). Its devices cite 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided Guangzhou Finecure Medical Equipment Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2013: 12015: 2
2013high 2 (2015) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Guangzhou Finecure Medical Equipment Co.,Ltd by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPIStimulator, Electrical, Non-Implantable, For Incontinence2decisions
  • IPFStimulator, Muscle, Powered1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K142369Urinary Incontinence SystemGuangzhou Finecure Medical Equipment Co.,Ltd · 2015
  • K140265Electrode for Urinary IncontinenceGuangzhou Finecure Medical Equipment Co.,Ltd · 2015
  • K130691Electrotherapy Device (Combo Unit)Guangzhou Finecure Medical Equipment Co.,Ltd · 2013

All 3 as Guangzhou Finecure Medical Equipment Co.,Ltd →