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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 DRIVE
COMPLIANCE DEPT.
HAMPTON,  VA  23666
Applicant Contact KIMBERLY ROSS
Correspondent
SPORT-ELEC
141 RESEARCH DRIVE
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
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