Clearance Summary
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 received FDA 510(k) clearance under submission number K112074, sponsored by Everyway Medical Instruments Co.,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 2012-02-01.
- Submission: K112074
- Applicant / Sponsor: Everyway Medical Instruments Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 2012-02-01
Classification & Regulation
This clearance is catalogued under FDA product code ITH and 21 CFR 890.5900, within the Physical Medicine review panel as a Class II device.