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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K131923
Device Name NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
Applicant
Techlink International
P.O. Box 694125
Miami,  FL  33269
Applicant Contact TARA CONRAD
Correspondent
Techlink International
P.O. Box 694125
Miami,  FL  33269
Correspondent Contact TARA CONRAD
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
GZJ  
Date Received06/26/2013
Decision Date 07/03/2014
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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