FDA 510(k) Application Details - K232193

Device Classification Name Wheelchair, Powered

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510(K) Number K232193
Device Name Wheelchair, Powered
Applicant Yurob Rehabilitation Medical Co.,Ltd.
No.93 Dianxing Road, Dianshanhu Town
Kunshan CN
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Contact Pan Daoping
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 07/25/2023
Decision Date 09/22/2023
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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