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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 K192308
Device Name Wu's Electrical Scooter
Applicant
Wu'S Tech Co., Ltd.
# 225, Yuan Peir St.
Hsin-Chu City,  TW 30093
Applicant Contact Jen Ke-Min
Correspondent
Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact Jen Ke-Min
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/26/2019
Decision Date 12/21/2020
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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