BREEZE C MODEL C (3W), BREEZE C (4W)— 510(k) K102304

Clearance details

Applicant

Afikim Electric Vehicles

Product code

Code INI

Device class

Class 2

Regulation

21 CFR 890.3800

Advisory panel

Physical Medicine

Date received

2010-08-16

Decision date

2011-01-07

Decision

Substantially Equivalent

Clearance type

Traditional

• K260094 — Mobility Scooter (W3465, W3902 (S50 Carbon))2026-08-10
• K260176 — Mobility Scooter (W3483, W3483A)2026-08-10
• K261232 — IERO Mobility Scooter (IERO-01)2026-07-14
• K261163 — Mobility Scooter (R200)2026-07-07
• K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F)2026-06-08

• K051028 — BREEZE2006-01-27
• K041186 — CADDY2004-09-09

Injury

171

Other

1

Total

172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0115-2014 — Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.Class II·Terminated·S.A.E. AFIKIM·20130927

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102304.