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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 K253257
Device Name Virgo Mobility Scooter (Virgo-D,Virgo-F)
Applicant
Jiangsu Intco Medical Products Co., Ltd.
# 298 Yandunshan Rd., Zhenjiang New District
Zhenjiang,  CN 212132
Applicant Contact Shiqun Liu
Correspondent
Shanghai Jiushun Enterprise Management Tech Service Co., Ltd.
Rm. 1502, Baoan Buiding, #800 Dongfang Rd.
Shanghai,  CN 200122
Correspondent Contact Doris Chen
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/29/2025
Decision Date 06/08/2026
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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