EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN

Stimulator, Nerve, Battery-powered

SUNMED LLC

The following data is part of a premarket notification filed by Sunmed Llc with the FDA for Easymed Peripheral Nerve Stimulator-sunstin.

Pre-market Notification Details

Device IDK121743
510k NumberK121743
Device Name:EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
ClassificationStimulator, Nerve, Battery-powered
Applicant SUNMED LLC C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan,  CN 528300
ContactWu Tingjie
CorrespondentWu Tingjie
SUNMED LLC C/O EASYMED INSTRUMENTS CO,5/ -6/F,BLOCK A,GUPO GONGMAO BLDG FENGXIN RD, FENGXIANG INDUSTRIAL DISTRICT Daliang, Shunde, Foshan,  CN 528300
Product CodeBXN  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-13
Decision Date2013-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10889483171486 K121743 000
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10889483005842 K121743 000
10889483005866 K121743 000
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10889483005958 K121743 000
10889483055557 K121743 000
10889483055564 K121743 000
10889483056516 K121743 000
10889483171394 K121743 000

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