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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
510(k) Number K014019
Device Name NEUROTECH MEDISTIM PLUS, TYPE 291
Applicant
Bio-Medical Research, Ltd.
Parkmore Business Park
Galway,  IE
Applicant Contact MICHELLE SAWYER
Correspondent
Bio-Medical Research, Ltd.
Parkmore Business Park
Galway,  IE
Correspondent Contact MICHELLE SAWYER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/06/2001
Decision Date 07/11/2002
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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