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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 K253241
Device Name Electric Wheelchair (Y207BL)
Applicant
Jiangsu Intco Medical Products Co., Ltd.
298# Yandunshan Rd.
Zhenjiang,  CN 212132
Applicant Contact Terry Gu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/29/2025
Decision Date 05/13/2026
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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