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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K092476
Device Name SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
Applicant
Sport-Elec
141 Research Dr.
Compliance Dept.
Hampton,  VA  23666
Applicant Contact KIMBERLY ROSS
Correspondent
Sport-Elec
141 Research Dr.
Compliance Dept.
Hampton,  VA  23666
Correspondent Contact KIMBERLY ROSS
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/12/2009
Decision Date 05/07/2010
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
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