FDA 510(k) Application Details - K182257

Device Classification Name Wheelchair, Standup

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510(K) Number K182257
Device Name Wheelchair, Standup
Applicant UPnRIDE Robotics Ltd.
Kochav Yokneam Bld.
Yokneam 2069204 IL
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Contact Yoram Levy
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Regulation Number 890.3900

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Classification Product Code IPL
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Date Received 08/21/2018
Decision Date 09/12/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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