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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 K070142
Device Name SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
Applicant
Bio-Medical Research Corp.
Parkmore Business Park W.
Galway,  IE
Applicant Contact ANNE-MARIE KEENAN
Correspondent
Bio-Medical Research Corp.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/16/2007
Decision Date 03/23/2007
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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