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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 K881753
Device Name ALPHA-STIM 350
Applicant
Electromedical Products, Inc.
12591 Crenshaw Blvd.
Hawthorne,  CA  90250
Applicant Contact DAVID SINGER
Correspondent
Electromedical Products, Inc.
12591 Crenshaw Blvd.
Hawthorne,  CA  90250
Correspondent Contact DAVID SINGER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/21/1988
Decision Date 08/30/1988
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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