GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES

Stimulator, Nerve, Transcutaneous, For Pain Relief

SELECTIVE MED COMPONENTS, INC.

The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Guardian Disposable Tens And Tens/nmes Electrodes.

Pre-market Notification Details

Device IDK945676
510k NumberK945676
Device Name:GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant SELECTIVE MED COMPONENTS, INC. 208 W. HIGH ST. Mt. Vernon,  OH  43050
ContactRichard J Fisher, Jr
CorrespondentRichard J Fisher, Jr
SELECTIVE MED COMPONENTS, INC. 208 W. HIGH ST. Mt. Vernon,  OH  43050
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-18
Decision Date1995-01-30

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