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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K903014
Device Name ALPHA-STIM CS
Applicant
ELECTROMEDICAL PRODUCTS, INC.
12591 CRENSHAW BLVD.
HAWTHORNE,  CA  90250
Applicant Contact DANIEL KIRSCH
Correspondent
ELECTROMEDICAL PRODUCTS, INC.
12591 CRENSHAW BLVD.
HAWTHORNE,  CA  90250
Correspondent Contact DANIEL KIRSCH
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received07/10/1990
Decision Date 05/12/1992
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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