510(k) Report

FDA applicant

Zhejiang Nysin Medical Co., Ltd.

Jinhua, CN4 decisions2024–20260 recalls

FDA records 4 decisions for Zhejiang Nysin Medical Co., Ltd. (Jinhua, CN) from 2024 to 2026: 4 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Since 2016 its 510(k)s took a median of 173 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. 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, physical medicine panel, where it files most

How often FDA has decided Zhejiang Nysin Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2024: 32026 (partial year): 1
2024high 3 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Zhejiang Nysin Medical Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhejiang Nysin Medical 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?

  • ITIWheelchair, Powered3decisions
  • INIVehicle, Motorized 3-Wheeled1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 173 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 125 days; 1 of its 4 were faster than that.

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 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.

  • K241529Powered Wheelchair (NXN20-209)Zhejiang Nysin Medical Co., Ltd. · 20241cites it

What has FDA decided for it lately?

  • K252275Electric Scooter (DDF100)Zhejiang Nysin Medical Co., Ltd. · 2026
  • K241529Powered Wheelchair (NXN20-209)Zhejiang Nysin Medical Co., Ltd. · 2024
  • K241603Powered Wheelchair (NXN20-208, NXN20-211)Zhejiang Nysin Medical Co., Ltd. · 2024
  • K241379Powered Wheelchair (NXN20-205, NXN20-205M)Zhejiang Nysin Medical Co., Ltd. · 2024

All 4 as Zhejiang Nysin Medical Co., Ltd. →