BREEZE

Vehicle, Motorized 3-wheeled

AFIKIM ELECTRIC VEHICLES

The following data is part of a premarket notification filed by Afikim Electric Vehicles with the FDA for Breeze.

Pre-market Notification Details

• Device ID: K051028
• 510k Number: K051028
• Device Name: BREEZE
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: AFIKIM ELECTRIC VEHICLES Kibbutz Afikim, IL 15148
• Contact: Avner Fishbein
• Correspondent: Avner Fishbein; AFIKIM ELECTRIC VEHICLES 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: 2005-04-22
• Decision Date: 2006-01-27
• Summary: summary