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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 K251606
Device Name Power Wheelchair (D26)
Applicant
Anhui Jbh Medical Apparatus Co., Ltd.
# 116 Qicang Rd., Industrial District, Ming Guang City
Chuzhou,  CN Anhui
Applicant Contact Yuanwei Wei
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/27/2025
Decision Date 06/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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