510(k) Report

FDA applicant

Guangdong Kaiyang Medical Technology Co., Ltd.

Foshan, CN2 decisions2010–20100 recalls

FDA records 2 decisions for Guangdong Kaiyang Medical Technology Co., Ltd. (Foshan, CN) in 2010: 2 510(k) clearances. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 2 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 Guangdong Kaiyang Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Guangdong Kaiyang Medical Technology Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IORWheelchair, Mechanical2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K101999Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 20102cite it
  • K101998Kaiyang Aluminum WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 20102cite it

What has FDA decided for it lately?

  • K101999Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010
  • K101998Kaiyang Aluminum WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010

All 2 as Guangdong Kaiyang Medical Technology Co., Ltd. →