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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 K262241
Device Name Electric Wheelchair (0080)
Applicant
Xuzhou Heabens Medical Technology Co., Ltd.
# 2 Industrial Concentration Zone, Liucheng Ave., Weimiao To
Xuzhou,  CN 221600
Applicant Contact Eric Wang
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/01/2026
Decision Date 09/29/2026
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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