Powered wheelchair (mobility robot) (M4, M4U)— 510(k) K242358

Name: FDA 510(k) clearance K242358
Creator: U.S. Food and Drug Administration
Published: 2025-04-03

Substantially Equivalent

Xsto Co., Ltd.

FDA 510(k) clearance K242358 for Powered wheelchair (mobility robot) (M4, M4U), Substantially Equivalent on 2025-04-03. Applicant: Xsto Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xsto Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2024-08-08
Decision date: 2025-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITI

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K260053 — Power Wheelchair (OS-R-M01I)2026-09-08
K260229 — Electric wheelchair (HC819N, HC830N, HC831N)2026-09-08
K261354 — Electric wheelchair (D03)2026-08-21
K261149 — Electric Wheelchair (DY611A-2, DY612A-1)2026-07-10
K261396 — Electric Wheelchair2026-07-08

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.