Lightfoot L80.2 Power Wheelchair
510(k) K850876
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850876 | Date16 May 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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).
Other devices from Ketronic, Inc.
Questions
AI-generated answers, 18 Sep 2026
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.