510(k) Report

FDA applicant

Counter Scientific Development (Gz), Ltd.

Guangzhou, CN4 decisions2014–20160 recalls

FDA records 4 decisions for Counter Scientific Development (Gz), Ltd. (Guangzhou, CN) from 2014 to 2016: 4 510(k) clearances. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). Its devices cite 4 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 Counter Scientific Development (Gz), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2014: 12015: 12016: 2
2014high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Counter Scientific Development (Gz), Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Counter Scientific Development (Gz)…’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?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K132993Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 20142cite it
  • K150277Pain Therapy System, Model PTS-IICounter Scientific Development (Gz), Ltd. · 20161cites it

What has FDA decided for it lately?

  • K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. · 2016
  • K150277Pain Therapy System, Model PTS-IICounter Scientific Development (Gz), Ltd. · 2016
  • K151279Counter OTC TENS Device, Model CSD-737ZCounter Scientific Development (Gz), Ltd. · 2015
  • K132993Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 2014

All 4 as Counter Scientific Development (Gz), Ltd. →