510(k) Report

FDA applicant

Ningbo Medkinetic Medical Device Co., Ltd.

Ningbo, CN1 decision2022–20220 recalls

FDA records 1 decision for Ningbo Medkinetic Medical Device Co., Ltd. (Ningbo, CN) in 2022: 1 510(k) clearance. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). 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 Ningbo Medkinetic Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 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 — Ningbo Medkinetic Medical Device Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K212377Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01Ningbo Medkinetic Medical Device Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K212377Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01Ningbo Medkinetic Medical Device Co., Ltd. · 2022

The one decision as Ningbo Medkinetic Medical Device Co., Ltd. →