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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 K052969
Device Name SLENDERTONE GYMBODY, MODEL 512-01
Applicant
Bio-Medical Research, Ltd.
Parkmore Business Park W.
Galway,  IE
Applicant Contact MICHAEL O'SULLIVAN
Correspondent
Bio-Medical Research, Ltd.
Parkmore Business Park W.
Galway,  IE
Correspondent Contact MICHAEL O'SULLIVAN
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/21/2005
Decision Date 11/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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