Transcutaneous Electrical Nerve Stimulator

Stimulator, Nerve, Transcutaneous, Over-the-counter

Top-Rank Health Care Co.,Ltd.

The following data is part of a premarket notification filed by Top-rank Health Care Co.,ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator.

Pre-market Notification Details

Device IDK210223
510k NumberK210223
Device Name:Transcutaneous Electrical Nerve Stimulator
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Top-Rank Health Care Co.,Ltd. Checun Village, Dongguan St. Shang-Yu District Shaoxing,  CN 312352
ContactJames Zhou
CorrespondentYuling Chen
Microkn Business Consulting (Shanghai) Co., Ltd. Room 1219, Block A, No3699, Gonghexin Road, Jingan District Shanghai,  CN 200040
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-28
Decision Date2021-12-15

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