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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 K062616
Device Name WELLNESSPRO 2010
Applicant
Intelsource Group, Inc.
1676 Village Green Suite A
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Intelsource Group, Inc.
1676 Village Green Suite A
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/05/2006
Decision Date 07/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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