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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 K191356
Device Name i3 Foldable Mobility Scooter
Applicant
Puc Perfect Union Co., Ltd.
8f-4, #20, Ln. 609, Sec. 5, Chungshin Rd.
Sanchung District
New Taipei City,  TW 241
Applicant Contact Anita Chen
Correspondent
Puc Perfect Union Co., Ltd.
8f-4, #20, Ln. 609, Sec. 5, Chungshin Rd.
Sanchung District
New Taipei City,  TW 241
Correspondent Contact Anita Chen
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/21/2019
Decision Date 01/11/2022
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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