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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 K173315
Device Name SupaChair Powered Wheelchair
Applicant
Eurogreen International Inc.
No. 48, Lane 220, Sec 1, Fu-Zun Rd., Yuan-Lin Township
Chang-Hua County,  CN 51055
Applicant Contact David Hsieh
Correspondent
Eurogreen International Inc.
No. 48, Lane 220, Sec 1, Fu-Zun Rd., Yuan-Lin Township
Chang-Hua County,  CN 51055
Correspondent Contact David Hsieh
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/19/2017
Decision Date 02/13/2018
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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