OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)

Stimulator, Nerve, Transcutaneous, Over-the-counter

SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.

The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Otc Electrical Stimulator (mt9001), Otc Tens Device (lt3060).

Pre-market Notification Details

Device IDK130802
510k NumberK130802
Device Name:OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong,  CN 518108
ContactJianping Kang
CorrespondentJianping Kang
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong,  CN 518108
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-22
Decision Date2013-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817915020012 K130802 000

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