Powered Wheelchair DYW30A(D09)

Wheelchair, Powered

Nanjing Jin Bai He Medical Apparatus Co., Ltd.

The following data is part of a premarket notification filed by Nanjing Jin Bai He Medical Apparatus Co., Ltd. with the FDA for Powered Wheelchair Dyw30a(d09).

Pre-market Notification Details

Device IDK170787
510k NumberK170787
Device Name:Powered Wheelchair DYW30A(D09)
ClassificationWheelchair, Powered
Applicant Nanjing Jin Bai He Medical Apparatus Co., Ltd. No. 61 Qinhuai Road, Jiangning Economic And Technological Development Zone Nanjing,  CN 211106
ContactJen Ke-min
CorrespondentJen Ke-min
Nanjing Jin Bai He Medical Apparatus Co., Ltd. No. 61 Qinhuai Road, Jiangning Economic And Technological Development Zone Nanjing,  CN 211106
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-16
Decision Date2017-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810058400314 K170787 000
00810058400307 K170787 000
06973175532314 K170787 000

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