510(k) Report

FDA applicant

Foshan Shunkangda Medical Tech Co., Ltd.

Foshan, CN1 decision2024–20240 recalls

FDA records 1 decision for Foshan Shunkangda Medical Tech Co., Ltd. (Foshan, CN) in 2024: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). 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 Foshan Shunkangda Medical Tech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

Planning a device like Foshan Shunkangda Medical Tech Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IORWheelchair, Mechanical1decision

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.

  • K242560Manual Wheelchair (SYIV100-CA9221)Foshan Shunkangda Medical Tech Co., Ltd. · 20241cites it

What has FDA decided for it lately?

  • K242560Manual Wheelchair (SYIV100-CA9221)Foshan Shunkangda Medical Tech Co., Ltd. · 2024

The one decision as Foshan Shunkangda Medical Tech Co., Ltd. →