510(k) Report

FDA applicant

Foshan Machinery & Equipment Import & Export Co.

Fort Lee, NJ1 decision1999–19990 recalls

FDA records 1 decision for Foshan Machinery & Equipment Import & Export Co. (Fort Lee, NJ) in 1999: 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 Machinery & Equipment Import & Export Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Foshan Machinery & Equipment Import & Export Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Foshan Machinery & Equipment Import & Export Co. 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

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.

  • K992884Wheelchair (Manual, Not Electrical)Foshan Machinery & Equipment Import & Export Co. · 19991cites it

What has FDA decided for it lately?

  • K992884Wheelchair (Manual, Not Electrical)Foshan Machinery & Equipment Import & Export Co. · 1999

The one decision as Foshan Machinery & Equipment Import & Export Co. →