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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 K253276
Device Name Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02)
Applicant
Shanghai Bangbang Robotics Co., Ltd.
Rm. 501, Bldg. 3, #188 Zhongchen Rd.
Songjiang District
Shanghai,  CN 201613
Applicant Contact Yihua Ma
Correspondent
Shanghai Bangbang Robotics Co., Ltd.
Rm. 501, Bldg. 3, #188 Zhongchen Rd.
Songjiang District
Shanghai,  CN 201613
Correspondent Contact Yihua Ma
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/29/2025
Decision Date 01/15/2026
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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