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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 K122744
Device Name PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
Original Applicant
PROSPERA CORPORATION
5776 stoneridge mall rd
suite 288
pleasanton,  CA  94588
Original Contact leon e jew
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/07/2012
Decision Date 03/28/2013
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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