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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K883462
Device Name IF-II (TM), MODEL 9800
Applicant
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Applicant Contact A MACFARLANE
Correspondent
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Correspondent Contact A MACFARLANE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received08/15/1988
Decision Date 05/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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