Clearance Summary
Nerivio, FGD000075-4.7 received FDA 510(k) clearance under submission number K203181, 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 2021-01-22.
- Submission: K203181
- Applicant / Sponsor: Theranica Bioelectronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5899
- Decision date: 2021-01-22
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.