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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, over-the-counter
510(K) Number K121757
Models PRO-8AB, PRO-8IS
Device Name HEALTHMATEFOREVER
Applicant
HEALTHMATE INTERNATIONAL, LLC
709 e. 97th street
kansas city,  MO  64131
Contact mei dodson
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received06/15/2012
Decision Date 11/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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