Clearance Summary
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption received FDA 510(k) clearance under submission number K230014, sponsored by Tonica Elektronik A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-08-25.
- Submission: K230014
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2023-08-25
Classification & Regulation
This clearance is catalogued under FDA product code QPL and 21 CFR 882.5890, within the Neurology review panel as a Class II device.