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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 K912348
Device Name SX90 (TM),MODEL 4800S
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 Number882.5890
Classification Product Code
GZJ  
Date Received05/28/1991
Decision Date 06/24/1991
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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