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 K081026
Device Name BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
Applicant
SPORT-ELEC S.A.
144 RESEARCH DRIVE
HAMPTON,  VA  23666
Applicant Contact SHARON SCANNELL
Correspondent
SPORT-ELEC S.A.
144 RESEARCH DRIVE
HAMPTON,  VA  23666
Correspondent Contact SHARON SCANNELL
Regulation Number890.5850
Classification Product Code
NGX  
Date Received04/10/2008
Decision Date 11/05/2008
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
-
-