Clearance Summary
Avid CT2 received FDA 510(k) clearance under submission number K202490, sponsored by Vision Quest Industries Inc./Dba VQ Orthocare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2020-11-16.
- Submission: K202490
- Applicant / Sponsor: Vision Quest Industries Inc./Dba VQ Orthocare
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2020-11-16
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.