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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 K113544
Device Name ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
Original Applicant
PROSPERA CORPORATION
405 boulder ct
suite 500
pleasanton,  CA  94566
Original Contact kevin walls
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/01/2011
Decision Date 07/27/2012
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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