FDA 510(k) Application Details - K241686

Device Classification Name Wheelchair, Powered

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510(K) Number K241686
Device Name Wheelchair, Powered
Applicant Zhejiang Zhonglei Medical Technology Co.Ltd.
1st floor, 2nd floor, No. 66, Dayuan Street,
Nanmingshan Street, Liandu District
Lishui CN
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Contact Chengwei Ying
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 06/12/2024
Decision Date 08/13/2024
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 K241686


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