FDA 510(k) Application Details - K240331

Device Classification Name Wheelchair, Powered

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510(K) Number K240331
Device Name Wheelchair, Powered
Applicant Yongkang Youha Electric Appliance Co.,Ltd.
4th Floor,Agricultural Equipment Science and Technology
Innovation Park,No.36,Huahai Road,Chengxi New District
Yongkang CN
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Contact Yongbo Li
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/05/2024
Decision Date 10/01/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240331


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