Dr.MUSIC 3s

Stimulator, Nerve, Transcutaneous, Over-the-counter

SmartMedicalDevice Co., Ltd.

The following data is part of a premarket notification filed by Smartmedicaldevice Co., Ltd. with the FDA for Dr.music 3s.

Pre-market Notification Details

Device IDK172451
510k NumberK172451
Device Name:Dr.MUSIC 3s
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant SmartMedicalDevice Co., Ltd. 32-19, Gobong-ro, Ilsandong-gu Goyang-si,  KR 10364
ContactDong-min Lee
CorrespondentCarmelina G. Allis
The Allis Law Firm, PLLC 2437 Bay Area Blvd., #30 Houston,  TX  77058
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-14
Decision Date2017-11-17
Summary:summary

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