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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 K935132
Device Name HOME MICROCURRENT HMC
Applicant
MEDICAL DEVICES, INC.
833 THIRD ST. SOUTHWEST
ST. PAUL,  MN  55112
Applicant Contact DANIEL D PILON
Correspondent
MEDICAL DEVICES, INC.
833 THIRD ST. SOUTHWEST
ST. PAUL,  MN  55112
Correspondent Contact DANIEL D PILON
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
GXY  
Date Received10/28/1993
Decision Date 03/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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