Data / Medical devices / Israel / Afikim Electric Vehicles (S.A.E. AFIKIM)
Afikim Electric Vehicles (S.A.E. AFIKIM): FDA-registered device maker in Kibbutz Afikim Northern, Israel, 5 510(k) clearances
Afikim Electric Vehicles (S.A.E. AFIKIM) is registered with the FDA (registration 8043457) in Kibbutz Afikim Northern, Israel. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 7, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043457
- FEI number
- 1000646143
- Address
- Kibbutz Afikim, Kibbutz Afikim Northern, Israel, 1514800
- Owner or operator
- Afikim Electric Vehicles (S.A.E. Afikim) (10025988)
- Roles
- Exporter to the US
- First device listed
- May 28, 2008
- Registered through
- 2026
- Brand names listed
- AFISCOOTERS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Exporter to the US | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 7, 2011 | K102304 | BREEZE C MODEL C (3W), BREEZE C (4W) | INI | Substantially Equivalent | Afikim Electric Vehicles | accessdata.fda.gov |
| January 27, 2006 | K051028 | BREEZE | INI | Substantially Equivalent | Afikim Electric Vehicles | accessdata.fda.gov |
| September 9, 2004 | K041186 | CADDY | ITI | Substantially Equivalent | Afikim Electric Vehicles | accessdata.fda.gov |
| November 26, 1990 | K904522 | VARIOUS MODELS OF WHEELCHAIRS | INI | Substantially Equivalent | Hadco Marketing Services, Inc. | accessdata.fda.gov |
| January 13, 1986 | K853918 | THE SPORTSTER (ELECTRIFIED WHEELCHAIR) | INI | Substantially Equivalent | Amigo Sales, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 27, 2013 | 66410 | Class II | Terminated | 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 | Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key. | accessdata.fda.gov |
Compare with other makers
Updated October 30, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.