510(k) Report

FDA applicant

Eurogreen International, Inc.

Chang-Hua County, CN4 decisions2015–20190 recalls

FDA records 4 decisions for Eurogreen International, Inc. (Chang-Hua County, CN) from 2015 to 2019: 4 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Eurogreen International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 12018: 22019: 1
2015high 2 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Eurogreen International, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eurogreen International, Inc.’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?

  • INIVehicle, Motorized 3-Wheeled2decisions
  • ITIWheelchair, Powered2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K143557SupaScoota Motorized vehicleEurogreen International, Inc. · 20151cites it
  • K173315SupaChair Powered WheelchairEurogreen International, Inc. · 20181cites it

What has FDA decided for it lately?

  • K182631SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)Eurogreen International, Inc. · 2019
  • K173315SupaChair Powered WheelchairEurogreen International, Inc. · 2018
  • K173313SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SPEurogreen International, Inc. · 2018
  • K143557SupaScoota Motorized vehicleEurogreen International, Inc. · 2015

All 4 as Eurogreen International, Inc. →