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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 K232121
Device Name Power wheelchair (Model:BC-EA8000)
Applicant
Ningbo Baichen Medical Devices Co., Ltd.
Rm. 903, 666 Taikang Middle Rd.,
Shouuhan St., Yinzhou, Yinzhou District
Ningbo,  CN
Applicant Contact Wu Xiao Long
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/17/2023
Decision Date 09/15/2023
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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