Vertran Standing Wheelchair
by Fena Design, Inc. 510(k)
Active
510(k) K011530
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011530 | Date16 Oct 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3900
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vertran Standing Wheelchair is a Standup Wheelchair (Device Type: K011530), designed to assist individuals with limited mobility in achieving an upright position. It features an external, manually operated mechanical system to elevate the seated user vertically, promoting physical function and independence. This device is classified under Physical Medicine and is intended for use by individuals restricted to a sitting position due to paraplegia or similar conditions. Its primary function is to enhance mobility and facilitate standing activities, such as transfers or weight-bearing exercises.
The Vertran Standing Wheelchair is supplied as a reusable medical device and is intended for use in clinical, home, or rehabilitation settings. It is not sterile upon delivery and requires cleaning and maintenance as specified by the manufacturer. The device is FDA-cleared under 510(k) (K011530) and falls under Device Class II (IPL product code). Multiple registration numbers (e.g., 3014653196) are associated with its regulatory compliance, governed under 21 CFR 890.3900. No MRI safety or sterility claims are stated in the specifications.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Vertran Standing Wheelchair?
The Vertran Standing Wheelchair is designed to assist individuals with restricted mobility—such as those with paraplegia or similar conditions—by enabling them to transition from a seated to a standing position. This promotes physical function, weight-bearing exercises, and greater independence during transfers or daily activities. The external mechanical system allows manual operation, making it accessible for users in clinical, home, or rehabilitation environments.
Is the Vertran Standing Wheelchair intended for single-use or reusable applications?
The Vertran Standing Wheelchair is classified as a reusable medical device. It is not sterile upon delivery and requires regular cleaning and maintenance as outlined by the manufacturer to ensure safe, prolonged use across clinical, home, or rehabilitation settings. Reusability extends its utility for long-term patient care.
What regulatory approvals apply to the Vertran Standing Wheelchair?
The Vertran Standing Wheelchair holds FDA clearance under the 510(k) pathway (K011530) and is categorized under Device Class II (IPL product code). It complies with 21 CFR 890.3900 and multiple registration numbers (e.g., 3014653196) reflect its regulatory oversight. No MRI safety or sterility claims are associated with this device.
In which settings is the Vertran Standing Wheelchair most commonly used?
The Vertran Standing Wheelchair is intended for use in clinical environments (e.g., hospitals, rehabilitation centers), home settings for long-term patients, and other mobility-limited care scenarios. Its design supports individuals who require assistance transitioning to a standing position, making it versatile for physical therapy, weight-bearing exercises, or daily transfers.
How does the mechanical elevation system of the Vertran Standing Wheelchair differ from other standing aids?
The Vertran Standing Wheelchair features an external, manually operated mechanical system distinct from motorized or electric alternatives. This design prioritizes simplicity and accessibility, allowing users or caregivers to control the elevation process without requiring power sources or complex controls. It is particularly suited for environments where battery-free or low-maintenance solutions are preferred.