Clearance Summary
Scooter, Model: R-100 received FDA 510(k) clearance under submission number K182411, sponsored by Yongkang Dingchang Industry & Trade 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 2019-06-24.
- Submission: K182411
- Applicant / Sponsor: Yongkang Dingchang Industry & Trade Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2019-06-24
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.