FDA 510(k) Application Details - K240270

Device Classification Name Wheelchair, Powered

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510(K) Number K240270
Device Name Wheelchair, Powered
Applicant Guangdong Prestige Technology Company Limited
No.8, Road.1,3rd Ind. District, Qiaotou Area, Houjie Town
Dongguan 523950 CN
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Contact Zhang Zhao
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 01/31/2024
Decision Date 08/27/2024
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 K240270


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