Electrically Powered Wheelchair (Model YC-01)— 510(k) K253980

Name: FDA 510(k) clearance K253980
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

Yurob Rehabilitation Medical Co., Ltd.

FDA 510(k) clearance K253980 for Electrically Powered Wheelchair (Model YC-01), Substantially Equivalent on 2026-03-27. Applicant: Yurob Rehabilitation Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yurob Rehabilitation Medical Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2025-12-12
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kunshan, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.