The following data is part of a premarket notification filed by Afikim Electric Vehicles with the FDA for Breeze C Model C (3w), Breeze C (4w).
| Device ID | K102304 |
| 510k Number | K102304 |
| Device Name: | BREEZE C MODEL C (3W), BREEZE C (4W) |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | AFIKIM ELECTRIC VEHICLES KIBBUTZ AFIKIM Kibbutz Afikim, IL 15148 |
| Contact | Avner Fishbein |
| Correspondent | Avner Fishbein AFIKIM ELECTRIC VEHICLES KIBBUTZ AFIKIM Kibbutz Afikim, IL 15148 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-16 |
| Decision Date | 2011-01-07 |