510(k) K112074
K112074 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800". The FDA issued a decision of Substantially Equivalent on February 1, 2012. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Everyway Medical Instruments Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2012
- Date Received
- July 20, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type