Clearance Summary
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 received FDA 510(k) clearance under submission number K172440, sponsored by Dongguan Prestige Sporting Goods., 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 2018-07-13.
- Submission: K172440
- Applicant / Sponsor: Dongguan Prestige Sporting Goods., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2018-07-13
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.