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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 K251891
Device Name Electric Wheelchair (GY-E001)
Applicant
Shandong Guyue Healthcare Appliance Co., Ltd.
#558,Xinwu Rd.,Binzhou Hi Tich Development Zone
Binzhou,  CN 256600
Applicant Contact Guangming Gou
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Kiwi Xu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/20/2025
Decision Date 09/09/2025
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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