BREEZE— 510(k) K051028

Substantially Equivalent

Afikim Electric Vehicles

FDA 510(k) clearance K051028 for BREEZE, Substantially Equivalent on 2006-01-27. Applicant: Afikim Electric Vehicles.

Clearance details

Applicant: Afikim Electric Vehicles
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2005-04-22
Decision date: 2006-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbutz Afikim, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.