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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 K240990
Device Name Mobility Scooter
Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
# 196 Industry Rd., Hengdian Movie Zone
Dongyang,  CN
Applicant Contact Grace Li
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/11/2024
Decision Date 09/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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