510(k) K112074

EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 by Everyway Medical Instruments Co.,Ltd — Product Code ITH

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