Scooter, Model: R-100

GUDID 06975991680019

Scooter, Model: R-100 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. 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.

Yongkang Dingchang Industry&Trade Co., Ltd.

Assistive scooter, electric-motor-driven

• Primary Device ID: 06975991680019
• NIH Device Record Key: e2940df5-4563-4387-a356-c52f3f165373
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scooter, Model: R-100
• Version Model Number: R100
• Company DUNS: 543031556
• Company Name: Yongkang Dingchang Industry&Trade Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975991680019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182411

FDA Product Code

• INI: Vehicle, Motorized 3-Wheeled

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-01-12

Devices Manufactured by Yongkang Dingchang Industry&Trade Co., Ltd.

• 06975991680019 - Scooter, Model: R-100: 2023-04-04Scooter, Model: R-100 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. 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.
• 06975991680019 - Scooter, Model: R-100: 2023-04-04 Scooter, Model: R-100 It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility
• 06975991680026 - Electric Wheelchair (XW-LY001): 2023-04-04 Electric Wheelchair (XW-LY001)
• 06975991680033 - Electric Wheelchair (XW-LY001): 2023-04-04 Electric Wheelchair (XW-LY001)