FDA 510(k) Application Details - K240563

Device Classification Name Wheelchair, Powered

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510(K) Number K240563
Device Name Wheelchair, Powered
Applicant ZheJiang J&J Mobility Co., Ltd
#18, Baiyang Street, Wuyi
Jinhua CN
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Contact Cheng Linda
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/29/2024
Decision Date 10/08/2024
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 K240563


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