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Walk on Wheels HS-3500 Electric Aisle Wheelchair

by Walk on Wheels Australia Pty, Ltd.

510(k) K120405

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120405 Date19 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 19 Sep 2026

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

The Walk on Wheels HS-3500 Electric Aisle Wheelchair is a Powered Wheelchair (OpenFDA classification) designed for indoor and outdoor use. It is an attendant-controlled mobility device intended to assist individuals with limited mobility or disabilities in navigating environments such as homes, hospitals, and public spaces. Its electric propulsion system enables smooth, controlled movement over various terrains, enhancing independence and accessibility for users.

This device is supplied as a reusable, non-sterile medical product and is classified under FDA regulation 890.3860 as a Class II device. It is intended for use in clinical and home settings, with no specific MRI safety restrictions noted. The HS-3500 is regulated under 510(k) clearance (K120405) and falls under the Physical Medicine specialty category. No single-use or sterilization requirements are indicated in the specifications.

Questions

AI-generated answers, 19 Sep 2026

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

  • What environments is the Walk on Wheels HS-3500 Electric Aisle Wheelchair designed to operate in?

    The HS-3500 is explicitly designed for both indoor and outdoor use, making it suitable for navigating homes, hospitals, and public spaces. Its electric propulsion system ensures smooth movement across various terrains, enhancing accessibility for users with limited mobility.

  • Is the Walk on Wheels HS-3500 Electric Aisle Wheelchair intended for single-use or reusable applications?

    The HS-3500 is classified as a reusable medical device and is not intended for single-use. There are no sterilization requirements specified, meaning it is meant for repeated use in clinical or home settings without needing sterilization between uses.

  • What type of regulatory clearance does the Walk on Wheels HS-3500 Electric Aisle Wheelchair hold, and how does it relate to its intended use?

    The HS-3500 holds FDA 510(k) clearance under the classification K120405, categorized as a Class II device under regulation 890.3860. This clearance confirms it is substantially equivalent to a predicate device and is regulated under the Physical Medicine specialty category, ensuring compliance for use as an attendant-controlled mobility aid.

  • Are there any special considerations for storing or handling the Walk on Wheels HS-3500 Electric Aisle Wheelchair?

    The device is supplied as a non-sterile product, so no special sterilization or sterile storage is required. However, since it is reusable, proper maintenance and cleaning protocols should be followed to ensure longevity and safe operation in both clinical and home environments.