Clearance Summary
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT received FDA 510(k) clearance under submission number K022518, sponsored by Roc Chinese-European Industrial Research Society. 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 2002-12-02.
- Submission: K022518
- Applicant / Sponsor: Roc Chinese-European Industrial Research Society
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2002-12-02
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.