Clearance Summary
eFOLDi Scooter, Lite received FDA 510(k) clearance under submission number K223492, sponsored by Suntech UK , 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 2023-02-22.
- Submission: K223492
- Applicant / Sponsor: Suntech UK , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2023-02-22
Classification & Regulation
This clearance is catalogued under FDA product code INI and 21 CFR 890.3800, within the Physical Medicine review panel as a Class II device.