Electric Wheelchair, Model: 9000N

Wheelchair, Powered

Silver Fox Corporation Limited

The following data is part of a premarket notification filed by Silver Fox Corporation Limited with the FDA for Electric Wheelchair, Model: 9000n.

Pre-market Notification Details

Device IDK221799
510k NumberK221799
Device Name:Electric Wheelchair, Model: 9000N
ClassificationWheelchair, Powered
Applicant Silver Fox Corporation Limited No. 18, 1st TongLe Road, TongLe Industrial Zone TangXia Town PengJiang District, JiangMen Guangdong,  CN
ContactChen Yan
CorrespondentIris Fung
Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou,  CN 510000
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-21
Decision Date2022-09-16

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