Electric Wheelchair (S500-6)— 510(k) K260335
Substantially EquivalentZhongshan Sulenz Intelligent Technology Co., Ltd.
FDA 510(k) clearance K260335 for Electric Wheelchair (S500-6), Substantially Equivalent on 2026-06-15. Applicant: Zhongshan Sulenz Intelligent Technology Co., Ltd.. Device class: 2.
Summary
Zhongshan Sulenz Intelligent Technology's Electric Wheelchair (S500-6) is filed under ITI, powered wheelchairs. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Sulenz filed from Zhongshan, China. The decision came 133 calendar days after FDA received it (February 2 to June 15, 2026).
Clearance details
- Applicant
- Zhongshan Sulenz 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
- Zhongshan, 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.