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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 K261079
Device Name Power Wheelchair (DC12)
Applicant
Anhui JBH Medical Apparatus Co., Ltd.
# 116 Qicang Rd., Industrial District, Ming Guang City
Chuzhou,  CN 239400
Applicant Contact Yuanwei Wei
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1 401 , Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/01/2026
Decision Date 10/06/2026
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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