Clearance Summary
Scooter (Model: FDB01) received FDA 510(k) clearance under submission number K201196, sponsored by Nanjing Jin Bai HE Medical Apparatus 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 2021-06-25.
- Submission: K201196
- Applicant / Sponsor: Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2021-06-25
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.