Clearance Summary
Electric Wheelchair (AL-208S-063) received FDA 510(k) clearance under submission number K253340, sponsored by Zhongshan A&J Medical Equipment Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2026-04-03.
- Submission: K253340
- Applicant / Sponsor: Zhongshan A&J Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2026-04-03
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.