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 Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K071951
Device Name COMFY SERIES: EV-804, EV-805 & EV-806
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received07/16/2007
Decision Date 09/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-