THE SPORTSTER (ELECTRIFIED WHEELCHAIR)— 510(k) K853918

Substantially Equivalent

Amigo Sales, Inc.

FDA 510(k) clearance K853918 for THE SPORTSTER (ELECTRIFIED WHEELCHAIR), Substantially Equivalent on 1986-01-13. Applicant: Amigo Sales, Inc..

Clearance details

Applicant: Amigo Sales, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1985-09-23
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, MI, US

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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.