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, Muscle, Powered, For Muscle Conditioning
510(k) Number K111476
Device Name CONTOUR TECHNOLOGY MUSCLE STIMULATOR
Applicant
Contour Technology
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Applicant Contact SARA PETRIE
Correspondent
Contour Technology
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact SARA PETRIE
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/27/2011
Decision Date 05/23/2012
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
-
-