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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 K222507
Device Name Mobility Scooter (Models: W3431Q, W3431R)
Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
# 196 Industry Rd., Hengdian Movie Zone
Dongyang,  CN
Applicant Contact Leo Zheng
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave., Shanghai 200122, China
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/18/2022
Decision Date 02/28/2023
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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