Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)— 510(k) K250158

Substantially Equivalent

Zhe Jiang Cleisman Industry and Trade Co.,Ltd

FDA 510(k) clearance K250158 for Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003), Substantially Equivalent on 2025-04-28. Applicant: Zhe Jiang Cleisman Industry and Trade Co.,Ltd.

Clearance details

Applicant: Zhe Jiang Cleisman Industry and Trade Co.,Ltd
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2025-01-21
Decision date: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lishui, CN

Download summary PDF View on FDA.gov ↗

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.