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 K061650
Device Name SELECT TENS, MODEL 4600S
Applicant
EMPI
599 CARDIGAN RD.
ST. PAUL,  MN  55126
Applicant Contact CARL BEAURLINE
Correspondent
EMPI
599 CARDIGAN RD.
ST. PAUL,  MN  55126
Correspondent Contact CARL BEAURLINE
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NYN  
Date Received06/13/2006
Decision Date 01/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-