Cavalier Scooters
by Electric Mobility Corp. 510(k)
Active
510(k) K991281
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991281 | Date27 Oct 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Electric Mobility Cavalier Scooters
- 510(k) Number
- FDA Product Code
- INI
- FDA applicant
- Electric Mobility, LLC
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cavalier Scooters are motorized, three-wheeled mobility devices designed for individuals with limited mobility. Classified as a vehicle under FDA regulation 890.3800, these scooters provide powered assistance for indoor and outdoor use, enhancing independence and accessibility for users.
These scooters are supplied as reusable devices, intended for use in home, clinical, or community settings. They are regulated under the FDA’s 510(k) clearance (K991281) as substantially equivalent to the predicate device, with no single-use or sterility requirements specified. Multiple model variants are listed under product code INI, adhering to Class II medical device standards for motorized mobility aids.
Other devices from Electric Mobility Corp.
Questions
AI-generated answers, 1 Oct 2026
What are the Cavalier motorized scooters designed for?
The Cavalier scooters are motorized, three-wheeled mobility devices intended to provide powered assistance for individuals with limited mobility. They are designed to enhance independence and accessibility in both indoor and outdoor environments, allowing users to navigate spaces more easily.
Are the Cavalier scooters single-use or reusable?
The Cavalier scooters are supplied as reusable devices. They are not classified as single-use, meaning they are built for repeated use in home, clinical, or community settings without requiring disposal after each use.
What regulatory approval do these scooters hold?
The Cavalier scooters are regulated under the FDA’s 510(k) clearance process, specifically cleared under K991281. They are classified as substantially equivalent to a predicate device and fall under product code INI, adhering to Class II medical device standards for motorized mobility aids.
Do these scooters come in multiple models?
Yes, the Cavalier scooters include multiple model variants, each listed under the product code INI. These variants cater to different user needs while maintaining compliance with FDA regulations for motorized mobility devices.
Are there any sterility requirements for the Cavalier scooters?
No, the Cavalier scooters do not have any specified sterility requirements. As reusable devices, they are intended for general use in non-sterile environments such as homes, clinics, or community spaces.