Y207 Electric Wheelchair

Wheelchair, Powered

Jiangsu Intco Medical Products Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Intco Medical Products Co., Ltd. with the FDA for Y207 Electric Wheelchair.

Pre-market Notification Details

Device IDK202482
510k NumberK202482
Device Name:Y207 Electric Wheelchair
ClassificationWheelchair, Powered
Applicant Jiangsu Intco Medical Products Co., Ltd. No. 77 Yandunshan Road Dagang Zhenjiang,  CN 212132
ContactWang Maokun
CorrespondentIvy Wang
Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, No.1500, Century Ave., Pudong New District Shanghai,  CN 200122
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2021-03-18

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