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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 K242387
Device Name Mobility Scooter (N3473)
Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
# 196 Industry Rd., Hengdian Movie Zone
Dongyang,  CN
Applicant Contact Shuangshuang Li
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/12/2024
Decision Date 10/11/2024
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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