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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 K896948
Device Name ALPHA-STIM CS
Applicant
Electromedical Products, Inc.
12591 Crenshaw Blvd.
Hawthorne,  CA  90250
Applicant Contact L KIRSCH
Correspondent
Electromedical Products, Inc.
12591 Crenshaw Blvd.
Hawthorne,  CA  90250
Correspondent Contact L KIRSCH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/13/1989
Decision Date 02/23/1990
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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