510(k) K102304 ยท INI Vehicle, Motorized 3-Wheeled
BREEZE C MODEL C (3W), BREEZE C (4W)
| Applicant | Afikim Electric Vehicles, IL |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Aug 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102304
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2013 | S.A.E. AFIKIM 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 ai Terminated |
INI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.