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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
Models PL009, PL009A, PL029
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 (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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