Clearance Summary
YuGo System received FDA 510(k) clearance under submission number K151955, sponsored by Biogaming , 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 2016-02-05.
- Submission: K151955
- Applicant / Sponsor: Biogaming , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 2016-02-05
Classification & Regulation
This clearance is catalogued under FDA product code LXJ and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.