Electrically Powered Wheelchair (YC-01)— 510(k) K263257

Name: FDA 510(k) clearance K263257
Creator: U.S. Food and Drug Administration
Published: 2026-10-13

Substantially Equivalent

Yurob Rehabilitation Medical Co., Ltd.

FDA 510(k) clearance K263257 for Electrically Powered Wheelchair (YC-01), Substantially Equivalent on 2026-10-13. Applicant: Yurob Rehabilitation Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Yurob Rehabilitation Medical Co., Ltd.
Product code: Product code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2026-09-17
Decision date: 2026-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Kunshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITI

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K263005 — Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)2026-10-28
K261155 — Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S)2026-10-26
K261156 — Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M)2026-10-26
K261169 — Power Wheelchair (D39)2026-10-14
K262652 — Electric Wheelchair (CN501)2026-10-13

More clearances from Yurob Rehabilitation Medical Co., Ltd.

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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.