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, Over-The-Counter
510(k) Number K131159
Device Name SMARTRELIEF
Applicant
CHATTEM, INC.
1715 WEST 38TH ST.
CHATTANOOGA,  TN  37409
Applicant Contact ERIC JOSEPH
Correspondent
CHATTEM, INC.
1715 WEST 38TH ST.
CHATTANOOGA,  TN  37409
Correspondent Contact ERIC JOSEPH
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received04/24/2013
Decision Date 07/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-