510(k) K260937— Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)

Substantially Equivalent

Shanghai Waylong Intelligent Technology Co.,Ltd

Clearance details

Applicant: Shanghai Waylong Intelligent Technology Co.,Ltd
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2026-03-20
Decision date: 2026-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.