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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 K003744
Device Name ENRAF-NONIUS ENDOMED 182 SYSTEM
Applicant
Henley Healthcare, Inc.
120 Industrial Blvd.
Sugar Land,  TX  77478
Applicant Contact REBECCA STOUT
Correspondent
Henley Healthcare, Inc.
120 Industrial Blvd.
Sugar Land,  TX  77478
Correspondent Contact REBECCA STOUT
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/04/2000
Decision Date 02/20/2002
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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