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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 K253806
Device Name Power Wheelchair (N5919 series)
Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
#196 Industry Rd., Hengdian Movie Zone
Dongyang,  CN 322118
Applicant Contact Yolanda Ge
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/28/2025
Decision Date 04/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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