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Lightfoot L80.2 Power Wheelchair

by Ketronic, Inc.

510(k) K850876

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 NumberK850876 Date16 May 1985ClearedStatusActive

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  • Withdrawn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)

Full name
Ligtvoet L80.2 Lightfoot L80.2 Power Wheelchair
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, 18 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 Lightfoot L80.2 Power Wheelchair is a battery-operated mobility device classified as a Powered Wheelchair. It is designed to provide independent mobility for individuals who require a seated position for movement, offering enhanced maneuverability and support in indoor and outdoor environments.

This device is intended for use in clinical and home settings, supplied as a reusable medical mobility aid. It is not specified as MRI-safe, and no details regarding sterility or single-use are provided. The Lightfoot L80.2 is regulated under FDA 510(k) clearance (K850876) and falls under the classification of Class II medical devices (ITI product code).

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Questions

AI-generated answers, 18 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 types of environments is the Lightfoot L80.2 Power Wheelchair designed to be used in?

    The Lightfoot L80.2 Power Wheelchair is specifically designed for use in both clinical settings, such as hospitals or rehabilitation centers, and home environments. Its battery-operated mobility features enhance maneuverability for individuals who require seated movement, making it suitable for indoor and outdoor use.

  • Is the Lightfoot L80.2 Power Wheelchair intended for single-use or can it be reused?

    The Lightfoot L80.2 Power Wheelchair is supplied as a reusable medical mobility aid. There are no indications in the provided data that it is intended for single-use, and it is classified as a reusable device.

  • How is the regulatory status of the Lightfoot L80.2 Power Wheelchair determined?

    The Lightfoot L80.2 Power Wheelchair has received FDA 510(k) clearance under the classification of Class II medical devices, with the clearance number K850876. It was determined to be substantially equivalent through a traditional review process by the Physical Medicine Advisory Committee.

  • Are there any specific details about the sterility or cleaning requirements for the Lightfoot L80.2 Power Wheelchair?

    The provided data does not specify any details regarding sterility or cleaning requirements for the Lightfoot L80.2 Power Wheelchair. Since it is a reusable device, it is likely intended to be cleaned and maintained according to standard hygiene practices for mobility aids.