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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K222729
Device Name Electrical Scooter, WT-T4QP2
Applicant
Wu’S Tech Co., Ltd.
# 225, Yuan Peir St.
Hsin-Chu City,  TW 30093
Applicant Contact Dr.Jen Ke-Min
Correspondent
Chinese European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 300113
Correspondent Contact Dr.Jen Ke-Min
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/08/2022
Decision Date 03/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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