DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS

Stimulator, Nerve, Transcutaneous, For Pain Relief

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Digital Transcutaneous Electrical Nerve Stimulator, Model Ev-803 Digital Tens.

Pre-market Notification Details

Device IDK020749
510k NumberK020749
Device Name:DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 1308 MORNINGSIDE PARK DR. Alpharetta,  GA  30022
ContactJay Mansour
CorrespondentJay Mansour
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 1308 MORNINGSIDE PARK DR. Alpharetta,  GA  30022
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-07
Decision Date2002-10-31
Summary:summary

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