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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 K223151
Device Name Nu-beca Transcutaneous Electrical Nerve Stimulation
Applicant
Nu-Beca & Maxcellent Co.
3F-1, No. 45, Dexing W. Rd
Taipei,  TW 111046
Applicant Contact David Tsai
Correspondent
TaiDoc Technology COrporation
B1-7F, No.127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Correspondent Contact Diana Sung
Regulation Number882.5890
Classification Product Code
NUH  
Date Received10/05/2022
Decision Date 07/19/2023
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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