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Cavalier Scooters

by Electric Mobility Corp. 510(k)

Active United States

510(k) K991281

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991281 Date27 Oct 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Electric Mobility Corp. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.