Clearance Summary
CODA CX1 MOTION ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K033514, sponsored by Charnwood Dynamics , Ltd.. 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 2004-01-06.
- Submission: K033514
- Applicant / Sponsor: Charnwood Dynamics , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 2004-01-06
Classification & Regulation
This clearance is catalogued under FDA product code LXJ and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.