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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 K170634
Device Name Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
Applicant
Advanced Vehicle Concepts , Ltd.
7 Stadium Way Cradock Rd.
Luton,  GB LU4 0JF
Applicant Contact Mark Nicholls
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Rajal A. Vaibhav
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/02/2017
Decision Date 11/29/2017
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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