HEALTH EXPERT ELCTRONIC STIMULATOR

Stimulator, Nerve, Transcutaneous, Over-the-counter

SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED

The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Health Expert Elctronic Stimulator.

Pre-market Notification Details

Device IDK133929
510k NumberK133929
Device Name:HEALTH EXPERT ELCTRONIC STIMULATOR
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED N0. 43 LONGFENG ROAD XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT Shenzhen City, Guangdong Province,  CN 518116
ContactLi Yang
CorrespondentLi Yang
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED N0. 43 LONGFENG ROAD XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT Shenzhen City, Guangdong Province,  CN 518116
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-23
Decision Date2014-11-12
Summary:summary

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