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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K242358
Device Name Powered wheelchair (mobility robot) (M4, M4U)
Applicant
Xsto Co., Ltd.
Floor 1, Buliding C, 555 Plant, Ma'An Cun Rd.,
Cuiheng New District
Zhongshan,  CN 528400
Applicant Contact Jingbu Xu
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/08/2024
Decision Date 04/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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