510(k) Report

FDA applicant

Foshan Dongfang Medical Equipment Manufactory (Ltd)

Foshan, Guangdong Province, CN1 decision2004–20040 recalls

FDA records 1 decision for Foshan Dongfang Medical Equipment Manufactory (Ltd) (Foshan, Guangdong Province, CN) in 2004: 1 510(k) clearance. All are in product code IOR (Wheelchair, Mechanical). Its devices cite 1 predicate, 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 Foshan Dongfang Medical Equipment Manufactory (Ltd)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Foshan Dongfang Medical Equipment Manufactory (Ltd) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Foshan Dongfang Medical Equipment Manufactory (Ltd) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IORWheelchair, Mechanical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K041814FS Series WheelchairFoshan Dongfang Medical Equipment Manufactory (Ltd) · 2004

The one decision as Foshan Dongfang Medical Equipment Manufactory (Ltd) →