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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 K864625
Device Name MYOPAC (TM), MODEL 9600
Applicant
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Applicant Contact BRUCE A MACFARLANE
Correspondent
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Correspondent Contact BRUCE A MACFARLANE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/25/1986
Decision Date 12/29/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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