510(k) Report

FDA applicant

Afikim Electric Vehicles

Kibbutz Afikim, IL3 decisions2004–20111 recall

FDA records 3 decisions for Afikim Electric Vehicles (Kibbutz Afikim, IL) from 2004 to 2011: 3 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). 1 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 Afikim Electric Vehicles’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Afikim Electric Vehicles 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?

  • INIVehicle, Motorized 3-Wheeled2decisions
  • ITIWheelchair, Powered1decision

What has FDA decided for it lately?

  • K102304Breeze C Model C (3W), Breeze C (4W)Afikim Electric Vehicles · 20111 recall
  • K051028BreezeAfikim Electric Vehicles · 2006
  • K041186CADDYAfikim Electric Vehicles · 2004

All 3 as Afikim Electric Vehicles →

What has been recalled?

1 recall linked to its devices; the latest:

  • K102304Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze…Sep 27, 2013Class II