Nuocande Plastic Manual Wheelchair Model NKD L07

Wheelchair, Mechanical

NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Ningbo Lecount Medical Technology Co., Ltd. with the FDA for Nuocande Plastic Manual Wheelchair Model Nkd L07.

Pre-market Notification Details

Device IDK151797
510k NumberK151797
Device Name:Nuocande Plastic Manual Wheelchair Model NKD L07
ClassificationWheelchair, Mechanical
Applicant NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. 57 LONGFEI ROAD, YUNLONG INDUSTRY ZONE, YINGZHOU DISTRICT Ningbo,  CN 315135
ContactCharles Shen
CorrespondentCharles Shen
Manton Business And Technology Services 37 Winding Ridge Oakland,  NJ  07436
Product CodeIOR  
CFR Regulation Number890.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-02
Decision Date2015-08-25
Summary:summary

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