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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wheelchair, powered
510(k) Number K221799
Device Name Electric Wheelchair, Model: 9000N
Applicant
Silver Fox Corporation Limited
No. 18, 1st TongLe Road, TongLe Industrial Zone
TangXia Town PengJiang District, JiangMen
Guangdong,  CN
Applicant Contact Chen Yan
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Room, Longxiang Garden, Tianhe District
Guangzhou,  CN 510000
Correspondent Contact Iris Fung
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/21/2022
Decision Date 09/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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