FDA 510(k) Application Details - K231110

Device Classification Name Wheelchair, Mechanical

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510(K) Number K231110
Device Name Wheelchair, Mechanical
Applicant Ningbo Shenyu Medical Equipment Co.,Ltd.
No.1318 West of Tanjialing Road,
Yuyao CN
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Contact Ding Jianjun
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 04/19/2023
Decision Date 06/16/2023
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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