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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 K231472
Device Name Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
Applicant
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
# 68 Xinfa Rd., Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Ryan Chen
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/22/2023
Decision Date 07/19/2023
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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