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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 K241641
Device Name Electric Wheelchair (YE200)
Applicant
Shenzhen Yattll Industry Co., Ltd.
Rm. 907, A&I International Center, # 8 Gaoerfu Blvd.,
Longhua Dist
Shenzhen,  CN 518100
Applicant Contact Kevin Shih
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/07/2024
Decision Date 01/11/2025
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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