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 K092142
Device Name SPORT-ELEC BODY CONTROL SYSTEM BS
Applicant
Sport-Elec
141 Research Dr.
Compliance Dept.
Hampton,  VA  23666
Applicant Contact KIMBERLY JONES
Correspondent
Sport-Elec
141 Research Dr.
Compliance Dept.
Hampton,  VA  23666
Correspondent Contact KIMBERLY JONES
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/15/2009
Decision Date 02/05/2010
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
-
-