Mobility Scooter (C4+)
by Yongkang Yile Vehicle Co., Ltd China EUDAMED510(k)
510(k) K234098
Product code INI
Overview
The Mobility Scooter (C4+) is a motorized, three-wheeled vehicle designed for personal mobility assistance. It is classified as a Class II medical device under FDA regulations and falls under the category of motorized three-wheeled vehicles, intended to provide independent mobility for individuals with limited mobility.
This device is supplied as a reusable product and is regulated under FDA 510(k) clearance (K234098) and the Medical Device Regulation (MDR). It is intended for use in indoor and outdoor environments, with multiple registration numbers (e.g., 3033905189) reflecting its compliance with regulatory requirements. The scooter is manufactured by Yongkang Yile Vehicle Co., Ltd., with specifications adhering to the Physical Medicine advisory committee classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK234098 | Date18 Apr 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- INI
- FDA applicant
- Yongkang Yile Vehicle Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Yongkang Yile Vehicle Co., Ltd
Questions
Is this mobility scooter intended for indoor use only, or can it also be used outdoors?
The Mobility Scooter (C4+) is designed for use in both indoor and outdoor environments. The device’s classification under the Physical Medicine advisory committee and its regulatory compliance (including FDA 510(k) clearance) reflect its intended versatility for mobility assistance across varied settings, not just indoors.
How is the Mobility Scooter (C4+) supplied, and is it meant for single-use or reusable applications?
The Mobility Scooter (C4+) is supplied as a reusable product, not for single-use. This aligns with its classification as a durable medical device intended for long-term use by individuals with limited mobility, rather than a disposable item.
What regulatory pathways does this scooter follow, and how does it demonstrate compliance?
The Mobility Scooter (C4+) follows the FDA 510(k) clearance pathway (K234098) and adheres to the Medical Device Regulation (MDR). Compliance is evidenced by multiple registration numbers (e.g., 3033905189) and its classification under FDA regulation 890.3800, confirming it meets regulatory standards for motorized three-wheeled mobility devices.
Who is the manufacturer, and where can I find contact information for inquiries?
The Mobility Scooter (C4+) is manufactured by Yongkang Yile Vehicle Co., Ltd.. For inquiries, you may contact David Shi at the manufacturer’s address: #46 Zerong Rd., Dahou Industrial Zone, Tangxian Town, Yongkang, China (321314).
Does this scooter come in different sizes or models, or is it a single standardized unit?
While the provided data does not specify exact size variations or distinct model numbers beyond the C4+ designation, the device is categorized under OpenFDA’s
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K234098
- EUDAMED