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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
Applicant
Prospera Corporation
5776 Stoneridge Mall Rd. Suite 288
Pleasanton,  CA  94588
Applicant Contact LEON E JEW
Correspondent
Prospera Corporation
5776 Stoneridge Mall Rd. Suite 288
Pleasanton,  CA  94588
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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