Manual Wheelchair, Model A011

Wheelchair, Mechanical

Ningbo Shenyu Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Shenyu Medical Equipment Co., Ltd. with the FDA for Manual Wheelchair, Model A011.

Pre-market Notification Details

Device IDK201461
510k NumberK201461
Device Name:Manual Wheelchair, Model A011
ClassificationWheelchair, Mechanical
Applicant Ningbo Shenyu Medical Equipment Co., Ltd. No. 1318 West Of Tanjialing Road Yuyao,  CN 315408
ContactZhou Yuefeng
CorrespondentVivi Shi
Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai,  CN 200122
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-02
Decision Date2021-05-21

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