Wireless Pain Relieve Device Model: LT5018C

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 Wireless Pain Relieve Device Model: Lt5018c.

Pre-market Notification Details

Device IDK173462
510k NumberK173462
Device Name:Wireless Pain Relieve Device Model: LT5018C
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen Dongdixin Technology Co.,Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha Shenzhen,  CN 51808
ContactSiping Yuan
CorrespondentSiping Yuan
Shenzhen Dongdixin Technology Co.,Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha Shenzhen,  CN 51808
Product CodeNUH  
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-08
Decision Date2017-12-08
Summary:summary

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