FDA 510(k) Application Details - K240079

Device Classification Name Wheelchair, Powered

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510(K) Number K240079
Device Name Wheelchair, Powered
Applicant Suzhou Ideal Medical Co., Ltd.
No.88 Huachi Street, Suzhou Industrial Park
Suzhou 215000 CN
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Contact Hu Qi
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 01/11/2024
Decision Date 08/09/2024
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 K240079


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