FDA 510(k) Application Details - K240638

Device Classification Name Wheelchair, Powered

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510(K) Number K240638
Device Name Wheelchair, Powered
Applicant Ningbo Youhuan Automation Technology Co., Ltd.
Room 103-24, No. 352, No. 277 Shui Street
No. 756 Tiantong South Road, Yinzhou District
Ningbo 315100 CN
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Contact Francis Xu
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 03/06/2024
Decision Date 09/16/2024
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

FDA Source Information for K240638


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