Clearance Summary
UPnRIDE received FDA 510(k) clearance under submission number K182257, sponsored by Upnride Robotics , 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 2019-09-12.
- Submission: K182257
- Applicant / Sponsor: Upnride Robotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 2019-09-12
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.