Identity
- Trade Name
- Scooter, Model: R-100 FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- R100 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975991680019 FDA UDI
- 510(k) Number
- K182411 FDA UDI
- FDA Product Code
- INI FDA UDI
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assistive scooter, electric-motor-driven
Scooter, Model: R-100 by Yongkang Dingchang Industry & Trade Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Yongkang Dingchang Industry & Trade Co., Ltd.
Sources (1)
- FDA UDI e2940df5-4563-4387-a356-c52f3f165373 34 fields · synced May 30, 2026