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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 K993420
Device Name CONTROL SOLUTIONS INC, MODEL CS3101
Applicant
Control Solutions, Inc.
508 W. 5th. Ave.
Naperville,  IL  60563
Applicant Contact JOHN HAYDEN
Correspondent
Control Solutions, Inc.
508 W. 5th. Ave.
Naperville,  IL  60563
Correspondent Contact JOHN HAYDEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/12/1999
Decision Date 07/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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