Scooter, Model: R-100

Primary DI
06975991680019
Brand
Scooter, Model: R-100
Company
Yongkang Dingchang Industry&Trade Co., Ltd.
Model
R100
Device description
Scooter, Model: R-100It 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.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.
Published
2023-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
INIVehicle, Motorized 3-Wheeled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INIVehicle, Motorized 3-WheeledPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182411000Scooter, Model: R-100Yongkang Dingchang Industry & Trade Co., Ltd.2019-06-24INI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975991680019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975991680019069759916800196975991680019

GMDN Terms#

Term, Definition table
TermDefinition
Assistive scooter, electric-motor-drivenA battery-powered, electric-motor-driven mobility device designed to be operated by a person with a disability and consisting of a seat over two rear wheels, a platform for the feet, and handlebars in front to turn one or two steerable front wheels connected via a steering-column. Commonly referred to as a mobility scooter, it is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543031556
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975991680026Electric Wheelchair (XW-LY001)XW-LY0012023-01-12
06975991680033Electric Wheelchair (XW-LY001)XW-LY0012023-01-12

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