FDA 510(k) Application Details - K221799

Device Classification Name Wheelchair, Powered

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510(K) Number K221799
Device Name Wheelchair, Powered
Applicant Silver Fox Corporation Limited
No. 18, 1st TongLe Road, TongLe Industrial Zone
TangXia Town PengJiang District, JiangMen
Guangdong CN
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Contact Chen Yan
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 06/21/2022
Decision Date 09/16/2022
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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