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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 K212090
Device Name Electric Scooter
Applicant
Anhui Jbh Medical Apparatus Co., Ltd.
#116 Qicang Rd., Industrial Park
Chuzhou,  CN
Applicant Contact Dandan Yang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Central Ave.
Mingguang,  CN Anhui
Correspondent Contact Ivy Wang
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/06/2021
Decision Date 04/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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