Clearance Summary
Nerivio received FDA 510(k) clearance under submission number K201824, sponsored by Theranica Bio-Electronics, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-10-23.
- Submission: K201824
- Applicant / Sponsor: Theranica Bio-Electronics, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5899
- Decision date: 2020-10-23
Classification & Regulation
This clearance is catalogued under FDA product code QGT and 21 CFR 882.5899, within the Neurology review panel as a Class II device.