Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)— 510(k) K260937
Substantially EquivalentShanghai Waylong Intelligent Technology Co.,Ltd
FDA 510(k) clearance K260937 for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK), Substantially Equivalent on 2026-06-24. Applicant: Shanghai Waylong Intelligent Technology Co.,Ltd. Device class: 2.
Summary
Shanghai Waylong Intelligent Technology's Smart Electric Wheelchair comes in four models: R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, and R1-Ultra-WK. It's filed under ITI, powered wheelchairs, and the record doesn't say how the models differ.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).
Waylong filed from Shanghai, China. Review took 96 calendar days (March 20 to June 24, 2026).
Clearance details
- Applicant
- Shanghai Waylong Intelligent Technology Co.,Ltd
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code ITI
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . 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.