Landlex Model S400X
by Cycling and Health Tech. Industry R&D Center
510(k) K050793
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050793 | Date7 Jul 2005 | 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- Withdrawn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
- 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
Overview
AI-generated summary, 1 Oct 2026
The Landlex Model S400X is a motorized three-wheeled vehicle designed for mobility assistance. Classified as a motorized scooter, it is intended to provide users with enhanced mobility, particularly for individuals with limited mobility or physical impairments. Its design incorporates a three-wheeled base for stability and maneuverability, making it suitable for indoor and outdoor use in controlled environments such as homes, clinics, or rehabilitation centers.
The Landlex Model S400X is powered by two 12-volt lead-acid DC batteries, offering a range of up to 35 kilometers (22 miles) per charge. It is supplied as a reusable device, intended for long-term use with periodic maintenance. The device has received FDA 510(k) clearance under the classification of a Class II medical device (regulation number 890.3800), with a review by the Physical Medicine Advisory Committee. No specific sterility or MRI safety information is provided, and its use is not restricted to sterile environments.
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Questions
AI-generated answers, 1 Oct 2026
What is the Landlex Model S400X used for?
The Landlex Model S400X is a motorized three-wheeled scooter intended to assist individuals with limited mobility or physical impairments. Its three-wheeled design enhances stability and maneuverability, making it suitable for both indoor and outdoor use in controlled environments like homes, clinics, or rehabilitation centers. It is not restricted to sterile environments and is not intended for MRI use.
How is the Landlex Model S400X powered, and what is its range?
The Landlex Model S400X is powered by two 12-volt lead-acid DC batteries. With this setup, it provides a range of up to 35 kilometers (approximately 22 miles) per full charge, making it suitable for extended use within its operational environment.
Is the Landlex Model S400X a single-use or reusable device?
The Landlex Model S400X is designed as a reusable device intended for long-term use. It requires periodic maintenance to ensure optimal performance and safety, which is typical for motorized mobility aids.
Does the Landlex Model S400X require any special storage conditions?
The Landlex Model S400X does not have specific sterility requirements, so it does not need to be stored in a sterile environment. However, to maintain its functionality and battery life, it should be stored in a dry, protected area away from extreme temperatures and direct sunlight. Properly charging the batteries periodically, even if the device is not in use, can help prolong its lifespan.
What regulatory approval does the Landlex Model S400X have?
The Landlex Model S400X has received FDA 510(k) clearance as a Class II medical device under regulation number 890.3800. This clearance was granted after review by the Physical Medicine Advisory Committee, confirming its substantial equivalence to a predicate device. The device is classified as a motorized scooter for mobility assistance.