Mobility Scooter (Model X-01, X-02)— 510(k) K242975

Substantially Equivalent

Wuyi Aichi Industry & Trade Co., Ltd.

FDA 510(k) clearance K242975 for Mobility Scooter (Model X-01, X-02), Substantially Equivalent on 2025-05-07. Applicant: Wuyi Aichi Industry & Trade Co., Ltd..

Clearance details

Applicant: Wuyi Aichi Industry & Trade Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2024-09-26
Decision date: 2025-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuyi City, CN

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.