EASY MED TN-28 C

Stimulator, Nerve, Transcutaneous, For Pain Relief

EASYMED INSTRUMENT CO., LTD.

The following data is part of a premarket notification filed by Easymed Instrument Co., Ltd. with the FDA for Easy Med Tn-28 C.

Pre-market Notification Details

Device IDK040253
510k NumberK040253
Device Name:EASY MED TN-28 C
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EASYMED INSTRUMENT CO., LTD. 2/F-3/F, NO.2 BEIHAI DA ROAD LUNJIAO, SHUNDE Guangdong,  CN 528303
ContactWu Tingjie
CorrespondentStefan Preiss
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-02-04
Decision Date2004-04-08
Summary:summary

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