Clearance Summary
Avid IF2 received FDA 510(k) clearance under submission number K183692, sponsored by Vision Quest Industries Inc./Dba VQ Orthocare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-06-12.
- Submission: K183692
- Applicant / Sponsor: Vision Quest Industries Inc./Dba VQ Orthocare
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2019-06-12
Classification & Regulation
This clearance is catalogued under FDA product code LIH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.