AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)— 510(k) K090966

Name: FDA 510(k) clearance K090966
Creator: U.S. Food and Drug Administration
Published: 2009-05-15

Substantially Equivalent

Svrc Industries, Inc.

FDA 510(k) clearance K090966 for AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000), Substantially Equivalent on 2009-05-15. Applicant: Svrc Industries, Inc.. Device class: 2.

Clearance details

Applicant: Svrc Industries, Inc.
Product code: Code INI
Device class: Class 2
Regulation: 21 CFR 890.3800
Advisory panel: Physical Medicine
Date received: 2009-04-06
Decision date: 2009-05-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Saginaw, MI, US

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.