Clearance Summary
Zhenjiang Assure Mechanical Wheelchair,model:K1 received FDA 510(k) clearance under submission number K231320, sponsored by Zhenjiang Assure Medical Equipment Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2023-06-05.
- Submission: K231320
- Applicant / Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2023-06-05
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.