Clearance Summary
QuickVision Ultimate rTMS received FDA 510(k) clearance under submission number K261228, sponsored by Brain Ultimate, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-08-14.
- Submission: K261228
- Applicant / Sponsor: Brain Ultimate, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2026-08-14
Classification & Regulation
This clearance is catalogued under FDA product code OBP and 21 CFR 882.5805, within the Neurology review panel as a Class II device.