NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS

Stimulator, Neuromuscular, External Functional

TECHLINK INTERNATIONAL

The following data is part of a premarket notification filed by Techlink International with the FDA for Neurodyn Portable Tens Nfes, Neurodyn Portable Tens.

Pre-market Notification Details

Device IDK131923
510k NumberK131923
Device Name:NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
ClassificationStimulator, Neuromuscular, External Functional
Applicant TECHLINK INTERNATIONAL PO BOX 694125 Miami,  FL  33269
ContactTara Conrad
CorrespondentTara Conrad
TECHLINK INTERNATIONAL PO BOX 694125 Miami,  FL  33269
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-26
Decision Date2014-07-03
Summary:summary

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