Clearance Summary
Nerivio; Nerivio Infinity received FDA 510(k) clearance under submission number K250405, 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 2025-05-14.
- Submission: K250405
- Applicant / Sponsor: Theranica Bio-Electronics, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5899
- Decision date: 2025-05-14
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.