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Scoota Bug Motorized Vehicle

by A-Bec Mobility, Inc. 510(k)

Active United States

510(k) K880424

Overview

The Scoota Bug is a Motorized Three-Wheeled Vehicle (Class II), designed as a mobility aid for individuals with limited ambulation. It provides powered outdoor transportation to assist users in navigating environments where walking is difficult or impractical. The device is battery-powered and intended for medical use in physical medicine settings, supporting independent mobility for disabled persons.

The Scoota Bug is supplied as a reusable, non-sterile medical device, intended for use in outdoor environments. It requires no special storage conditions beyond those specified by the manufacturer. The device holds an FDA 510(k) clearance (K880424) under the INI product code, with a decision date of February 16, 1988. No MRI safety or single-use specifications are noted in the regulatory data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880424 Date16 Feb 1988ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
INI
Device Class
Class II
Regulation
21 CFR Part 890.3800
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Scoota Bug used for?

    The Scoota Bug is a motorized three-wheeled vehicle designed as a mobility aid for individuals with limited ambulation. It provides powered outdoor transportation to help users navigate environments where walking is difficult or impractical, supporting independent mobility for disabled persons in physical medicine settings.

  • Is the Scoota Bug reusable or single-use?

    The Scoota Bug is supplied as a reusable medical device. It is not intended for single-use and can be used repeatedly by authorized users, provided it is maintained according to the manufacturer’s guidelines.

  • Does the Scoota Bug require special storage conditions?

    No special storage conditions are required beyond those specified by the manufacturer. The device is non-sterile and intended for outdoor use, so standard care and maintenance practices apply.

  • Is the Scoota Bug safe for use near MRI machines?

    The regulatory data for the Scoota Bug does not specify MRI safety information. Users should consult the manufacturer’s instructions and ensure the device is not exposed to MRI environments unless explicitly approved for such use.

  • What regulatory approval does the Scoota Bug hold?

    The Scoota Bug holds an FDA 510(k) clearance (K880424) under the INI product code, with a decision date of February 16, 1988. This clearance indicates it is classified as a Class II medical device and is substantially equivalent to a predicate device.