Data / Medical devices / United States / Afikim Electric Vehicles Usa Inc
Afikim Electric Vehicles Usa Inc: FDA-registered device maker in Daytona Beach, FL, United States, 5 510(k) clearances
Afikim Electric Vehicles Usa Inc is registered with the FDA (registration 3015992762) in Daytona Beach, FL, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 7, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015992762
- Address
- 1011 8TH Street, Suite 104, Daytona Beach, FL, United States, 32117
- Owner or operator
- AFIKIM ELECTRIC VEHICLES USA INC (10062160)
- Roles
- Repackager or relabeler
- First device listed
- December 21, 2023
- Registered through
- 2026
- Brand names listed
- AFIKIM ELECTRIC VEHICLES
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Repackager or relabeler | 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 |
Compare with other makers
Updated January 7, 2011. 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.