BREEZE— 510(k) K051028

Name: FDA 510(k) clearance K051028
Creator: U.S. Food and Drug Administration
Published: 2006-01-27

Substantially Equivalent

Afikim Electric Vehicles

FDA 510(k) clearance K051028 for BREEZE, Substantially Equivalent on 2006-01-27. Applicant: Afikim Electric Vehicles. Device class: 2.

Clearance details

Applicant: Afikim Electric Vehicles
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
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 ↗

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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.