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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 K123866
Device Name TANYX
Applicant
Medecell Us, Inc.
144 Research Dr.
Hampton,  VA  23666
Applicant Contact RHONDA ALEXANDER, M.S., M.P.A.
Correspondent
Medecell Us, Inc.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact RHONDA ALEXANDER, M.S., M.P.A.
Regulation Number882.5890
Classification Product Code
NUH  
Date Received12/17/2012
Decision Date 09/13/2013
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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