Portable Folding Electric Wheelchair (Model: DC01)

Wheelchair, Powered

Anhui JBH Medical Apparatus Co., Ltd

The following data is part of a premarket notification filed by Anhui Jbh Medical Apparatus Co., Ltd with the FDA for Portable Folding Electric Wheelchair (model: Dc01).

Pre-market Notification Details

Device IDK212092
510k NumberK212092
Device Name:Portable Folding Electric Wheelchair (Model: DC01)
ClassificationWheelchair, Powered
Applicant Anhui JBH Medical Apparatus Co., Ltd No. 116 Qicang Road Mingguang City, Chuzhou,  CN 239400
ContactYang Dandan
CorrespondentIvy Wang
Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, No.1500, Century Ave., Pudong New District Shanghai,  CN 200122
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-06
Decision Date2022-05-06

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