FDA 510(k) Application Details - K251606

Device Classification Name Wheelchair, Powered

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510(K) Number K251606
Device Name Wheelchair, Powered
Applicant Anhui JBH Medical Apparatus Co., Ltd.
No. 116 Qicang Road, Industrial District, Ming Guang City
Chuzhou Anhui CN
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Contact Yuanwei Wei
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 05/27/2025
Decision Date 06/25/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K251606


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