Clearance Summary
Nerivio received FDA 510(k) clearance under submission number K223169, sponsored by Theranica Bioelectronics , 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 2023-02-06.
- Submission: K223169
- Applicant / Sponsor: Theranica Bioelectronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5899
- Decision date: 2023-02-06
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.