Electric Wheelchair (AL-208S-063)— 510(k) K253340
Substantially EquivalentZhongshan A&J Medical Equipment Co., Ltd.
FDA 510(k) clearance K253340 for Electric Wheelchair (AL-208S-063), Substantially Equivalent on 2026-04-03. Applicant: Zhongshan A&J Medical Equipment Co., Ltd.. Device class: 2.
Summary
Zhongshan A&J Medical Equipment's Electric Wheelchair (model AL-208S-063) is filed under product code ITI (Wheelchair, Powered).
Class II, 21 CFR 890.3860. It came in as a Traditional 510(k), and Physical Medicine is both the classification panel and the review panel.
Zhongshan A&J Medical Equipment filed from Zhongshan, China. Review took 185 calendar days (September 30, 2025 to April 3, 2026).
Clearance details
- Applicant
- Zhongshan A&J Medical Equipment 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 allMore clearances from Zhongshan A&J Medical Equipment Co., Ltd.
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.