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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 K241463
Device Name Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)
Applicant
Suzhou Master Machinery Manufacturing Co.,Ltd
2f, Block B, # 379, Delan Industrial Park, Zhangpu Town
Kunshan,  CN
Applicant Contact Hongying Wu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/23/2024
Decision Date 07/18/2024
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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