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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 K262582
Device Name Electric wheelchair (GP100)
Applicant
Suzhou Green Pine Medical Co., Ltd.
#103, 1st Floor, Bldg. 1, 338 Xinsheng Rd., Huaqiao Town, Ku
Suzhou,  CN 215300
Applicant Contact Guohua Wu
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 Received07/27/2026
Decision Date 09/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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