Electric Wheelchair (Model P2)— 510(k) K252428

Substantially Equivalent

Superpi Robot Co., Ltd.

FDA 510(k) clearance K252428 for Electric Wheelchair (Model P2), Substantially Equivalent on 2025-09-18. Applicant: Superpi Robot Co., Ltd..

Clearance details

Applicant: Superpi Robot Co., Ltd.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2025-08-01
Decision date: 2025-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, 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.