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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K182257
Device Name UPnRIDE
Applicant
Upnride Robotics , Ltd.
Kochav Yokneam Bld.
Yokneam,  IL 2069204
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number890.3900
Classification Product Code
IPL  
Date Received08/21/2018
Decision Date 09/12/2019
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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