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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
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