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 K161974
Device Name SLENDERTONE® Connect Abs, Type 570
Applicant
Bio-Medical Research Ltd.
Parkmore Business Park West
Galway,  IE H91 NHT7
Applicant Contact Anne-Marie Keenan
Correspondent
Bio-Medical Research Ltd.
Parkmore Business Park West
Galway,  IE H91 NHT7
Correspondent Contact Anne-Marie Keenan
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/18/2016
Decision Date 11/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-