Clearance Summary
Electric Wheelchair (XW-LY001) received FDA 510(k) clearance under submission number K200423, sponsored by Yongkang Dingchang Industry & Trade 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 2021-09-22.
- Submission: K200423
- Applicant / Sponsor: Yongkang Dingchang Industry & Trade Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2021-09-22
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.