FDA 510(k) Application Details - K242560

Device Classification Name Wheelchair, Mechanical

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510(K) Number K242560
Device Name Wheelchair, Mechanical
Applicant Foshan Shunkangda Medical Tech Co., Ltd.
Pingnan Industrial Area, Guicheng Nanhai District,
Foshan City, Guangdong, CN.
Foshan CN
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Contact Ruizhuo Xu
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 08/28/2024
Decision Date 10/24/2024
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 K242560


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