Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Equipment, Traction, Powered
510(k) Number K112074
Device Name EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
Applicant
Everyway Medical Instruments Co.,Ltd
845 Aronson Lake Ct.
Roswell,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
Everyway Medical Instruments Co.,Ltd
845 Aronson Lake Ct.
Roswell,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/20/2011
Decision Date 02/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-