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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K210223
Device Name Transcutaneous Electrical Nerve Stimulator
Applicant
Top-Rank Health Care Co.,Ltd.
Checun Village, Dongguan St. Shang-Yu District
Shaoxing,  CN 312352
Applicant Contact James Zhou
Correspondent
Microkn Business Consulting (Shanghai) Co., Ltd.
Room 1219, Block A, No3699, Gonghexin Road, Jingan District
Shanghai,  CN 200040
Correspondent Contact Yuling Chen
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/28/2021
Decision Date 12/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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