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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 K234098
Device Name Mobility Scooter (C4+)
Applicant
Yongkang Yile Vehicle Co., Ltd.
#46 Zerong Rd.
Dahou Industrial Zone, Tangxian Town
Yongkang,  CN 321314
Applicant Contact David Shi
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
377 Tianzhu Rd., Jiading
Shanghai,  CN 201801
Correspondent Contact Evan hu
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/26/2023
Decision Date 04/18/2024
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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