Levo-Stand-Up Wheelchair
by Marion Laboratories, Inc. 510(k)
Active
510(k) K790265
Overview
The Levo Stand-Up Wheelchair is a mobility aid classified as a stand-up wheelchair under the FDA’s nomenclature. It is designed to assist individuals with limited mobility in transitioning from a seated to a standing position, promoting independence and improving circulation and posture during use. This device is intended for patients requiring intermittent standing to alleviate pressure sores, enhance comfort, or support physical therapy regimens.
The Levo Stand-Up Wheelchair is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K790265) as a Class II device (IPL product code). It is intended for use in clinical settings such as physical medicine rehabilitation facilities, where patients can safely transition between seated and standing positions. No specific sterility requirements are noted in the regulatory data, and its design does not indicate MRI compatibility. The device is manufactured by Marion Laboratories, Inc., with no additional size or storage specifications provided in the submitted documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790265 | Date13 Feb 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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