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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 K250729
Device Name Power Wheelchair (MOB1107)
Applicant
Vive Health, LLC
8599 Fontana Del Sol Way
Naples,  FL  34109
Applicant Contact Guy Savioli
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 Received03/11/2025
Decision Date 07/02/2025
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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