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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K132832
Device Name ACTIVAPATCH ET IONTOPHORESIS PATCH
Applicant
Activatek, Inc.
2734 S. 3600 W.
Unit F
West Valley City,  UT  84119
Applicant Contact JAMAL YANAKI
Correspondent
Activatek, Inc.
2734 S. 3600 W.
Unit F
West Valley City,  UT  84119
Correspondent Contact JAMAL YANAKI
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received09/10/2013
Decision Date 02/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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