Clearance Summary
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3 received FDA 510(k) clearance under submission number K024329, sponsored by Ji-Ee Industry 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 2003-03-21.
- Submission: K024329
- Applicant / Sponsor: Ji-Ee Industry Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2003-03-21
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.