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
06973175530075 K170787 000
06973175530112 K170787 000
06973175530150 K170787 000
06973175530167 K170787 000
06973175530181 K170787 000
06973175530266 K170787 000
06973175530679 K170787 000
06973175532314 K170787 000
00810058400307 K170787 000
06973175530006 K170787 000

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