Clearance Summary
DYNATRON 360 RANGE OF MOTION TESTING DEVICE received FDA 510(k) clearance under submission number K897178, sponsored by Dynatronics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-04-18.
- Submission: K897178
- Applicant / Sponsor: Dynatronics Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1990-04-18
Classification & Regulation
This clearance is catalogued under FDA product code KQX and 21 CFR 888.1500, within the Orthopedic review panel as a Class I device.