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510(k) Data Aggregation
K Number
K201196Device Name
Scooter (Model: FDB01)
Manufacturer
Nanjing Jin Bai He Medical Apparatus Co., Ltd
Date Cleared
2021-06-25
(417 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jin Bai He Medical Apparatus Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
The Scooter (Models: FDB01) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, 2 rechargeable Lithium-Ion Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.
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K Number
K170787Device Name
Powered Wheelchair DYW30A(D09)
Manufacturer
Nanjing Jin Bai He Medical Apparatus Co., Ltd.
Date Cleared
2017-08-09
(146 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jin Bai He Medical Apparatus Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
Device Description
The powered wheelchair DYW30A(D09) is driven by two DC motors, and is suitable for indoor uses. It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The powered wheelchair DYW30A(D09) comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable.
It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The device is powered by two 12 volt / 6 Ah Lithium-ion batteries with 11.2 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz), when the device is not in use.
The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of DYW30A(D09) is 264 lbs and its maximum speed is 3.75 mph.
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