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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 K252494
Device Name Electrically powered wheelchair (KZ301B)
Applicant
Nanjing Kangni Smart Technology Co., Ltd.
#4 Gupinggang, Gulou District
#11 Hengjing Rd., Economic & Technological Development Zone
Nanjing,  CN
Applicant Contact Huilin Yu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/08/2025
Decision Date 12/05/2025
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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