XINIWAVE, MODEL XW-18

Stimulator, Nerve, Transcutaneous, Over-the-counter

INTERNATIONAL TRADE GROUP, INC.

The following data is part of a premarket notification filed by International Trade Group, Inc. with the FDA for Xiniwave, Model Xw-18.

Pre-market Notification Details

Device IDK100441
510k NumberK100441
Device Name:XINIWAVE, MODEL XW-18
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. Oxford,  OH  45056
ContactBrent C Reider
CorrespondentBrent C Reider
INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. Oxford,  OH  45056
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-17
Decision Date2010-07-15
Summary:summary

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