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Rangeroller (Modified)

by Excel Mobility Products, Inc. 510(k)

Active United States

510(k) K920325

Overview

The Rangeroller (Modified) is a Powered Wheelchair designed to assist individuals with limited mobility in transferring and repositioning within their wheelchair. It features a modified rolling mechanism to enhance maneuverability and ease of use for users requiring enhanced mobility support in physical medicine applications.

This device is intended for single-use or reusable applications in clinical and home settings, depending on facility protocols. It has been cleared under FDA 510(k) K920325 as substantially equivalent to predicate devices, adhering to 21 CFR 890.3860 for powered wheelchairs. No specific MRI safety or sterility requirements are noted in the regulatory data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920325 Date6 Mar 1992ClearedStatusActive

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
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Excel Mobility Products, Inc.

  • Rangeroller

    Class II

Questions

  • What is the primary purpose of the Rangeroller (Modified) in clinical settings?

    The Rangeroller (Modified) is designed to assist individuals with limited mobility by enhancing their ability to transfer and reposition within their wheelchair. Its modified rolling mechanism improves maneuverability, making it particularly useful for users who require additional mobility support in physical medicine applications.

  • Can the Rangeroller (Modified) be used in both clinical and home environments?

    Yes, the Rangeroller (Modified) is intended for use in both clinical and home settings, though whether it is used as single-use or reusable depends on facility protocols. The device’s design supports flexibility in these environments.

  • How is the Rangeroller (Modified) regulated, and what does that mean for its use?

    The Rangeroller (Modified) has been cleared under FDA 510(k) number K920325 as substantially equivalent to predicate devices, adhering to 21 CFR 890.3860 for powered wheelchairs. This means it meets FDA standards for safety and effectiveness as a powered wheelchair, but it does not imply any specific MRI safety or sterility requirements.

  • Are there different models or sizes available for the Rangeroller (Modified)?

    The provided data lists multiple FEI numbers (e.g., 3014522447, 3021071770) associated with the Rangeroller (Modified), which may indicate variations in models or configurations. However, specific details about sizes, weight capacities, or distinct model features are not provided in the data.

  • Does the Rangeroller (Modified) require any special storage conditions?

    The data does not specify any special storage requirements for the Rangeroller (Modified). However, as a powered wheelchair, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to ensure optimal performance and longevity.