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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K854761
Device Name MINIPAC PERSONAL TOUCH (TM)
Applicant
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Applicant Contact MACFARLANE PHD
Correspondent
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Correspondent Contact MACFARLANE PHD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/27/1985
Decision Date 02/14/1986
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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