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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 K181344
Device Name C.T.M Mobility Scooter
Applicant
Chien TI Enterprise Co., Ltd.
# 13, Ln. 227, Fu Ying Rd.
New Taipei City, Hsin Chuang District,  CN 24258
Applicant Contact Vivian Lo
Correspondent
Chien TI Enterprise Co., Ltd.
# 13, Ln. 227, Fu Ying Rd.
New Taipei City, Hsin Chuang District,  CN 24258
Correspondent Contact Vivian Lo
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/21/2018
Decision Date 12/14/2018
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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