FDA 510(k) Application Details - K231750

Device Classification Name Wheelchair, Mechanical

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510(K) Number K231750
Device Name Wheelchair, Mechanical
Applicant Sichuan AST Medical Equipment Co., Ltd.
No.58 JinPeng Road, Area C, West Industrial Park
Luxian County
Luzhou City 646100 CN
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Contact Mae Tse
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 06/15/2023
Decision Date 08/15/2023
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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