Clearance Summary
Scooter received FDA 510(k) clearance under submission number K182471, sponsored by Tianjin Kepler Vehicle 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 2019-07-10.
- Submission: K182471
- Applicant / Sponsor: Tianjin Kepler Vehicle Industry Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2019-07-10
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.