Scooter (Model: FDB01)

Vehicle, Motorized 3-wheeled

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 Scooter (model: Fdb01).

Pre-market Notification Details

Device IDK201196
510k NumberK201196
Device Name:Scooter (Model: FDB01)
ClassificationVehicle, Motorized 3-wheeled
Applicant Nanjing Jin Bai He Medical Apparatus Co., Ltd No. 12, Wuge Rd, Jiangning Nanjing,  CN 210000
ContactDandan Yang
CorrespondentIvy Wang
Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai,  CN 200122
Product CodeINI  
CFR Regulation Number890.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2021-06-25

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