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510(k) Data Aggregation
K Number
K200423Device Name
Electric Wheelchair (XW-LY001)
Manufacturer
Date Cleared
2021-09-22
(580 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
**Yongkang Dingchang Industry **& Trade Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Model XW-LY001 Electric wheelchair is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. It is suitable to be used in low speed, good road condition and small slope. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The subject device has 8 inch front wheel and 12.5 inch rear wheel. The motor of electric wheelchair is DC24V 200W; the battery is 25.2V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kgs, and its maximum speed is 6km/h. The braking time is about 2-3s,and the braking distance is ≤1.5m
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K Number
K182411Device Name
Scooter, Model: R-100
Manufacturer
Date Cleared
2019-06-24
(293 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
**Yongkang Dingchang Industry **& Trade Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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: R-100) 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 aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. 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.
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