510(k) Report

FDA applicant

Ningbo Shenyu Medical Equipment Co.,Ltd

Yuyao, CN4 decisions2021–20260 recalls

FDA records 4 decisions for Ningbo Shenyu Medical Equipment Co.,Ltd (Yuyao, CN) from 2021 to 2026: 4 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 3 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2025

2021: 12023: 12025: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ningbo Shenyu Medical Equipment Co.,Ltd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ningbo Shenyu Medical Equipment 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?

  • IORWheelchair, Mechanical3decisions
  • ITIWheelchair, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 58 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K201461Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 20216cite it

What has FDA decided for it lately?

  • K253599Electric Wheelchair (W-A807, W-A807L)Ningbo Shenyu Medical Equipment Co.,Ltd · 2026
  • K252517Manual Wheelchair (SYIV100A008)Ningbo Shenyu Medical Equipment Co.,Ltd · 2025
  • K231110Manual Wheelchair (A006)Ningbo Shenyu Medical Equipment Co.,Ltd · 2023
  • K201461Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021

All 4 as Ningbo Shenyu Medical Equipment Co.,Ltd →