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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K233010
Device Name Beagank 4T Plus
Belega Inc.
1-4-20 Sonezaki Shinchi
Kita-Ku,  JP 530-0002
Applicant Contact Masayuki Okumura
Ken Block Consulting Co., Ltd.
1-9-9 Tsukiji
Chuo-ku,  JP 104-0045
Correspondent Contact Nana Nagashita
Regulation Number882.5890
Classification Product Code
Date Received09/22/2023
Decision Date 11/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No