Levo C3 Standup Wheelchair
by Levo AG EUDAMED510(k)
Active
510(k) K083017
Overview
The Levo C3 Standup Wheelchair is a powered mobility device designed to assist individuals with physical disabilities in transitioning between seated and standing positions. Classified as a Class II medical device under FDA regulations, it incorporates mechanical and electrical components to provide active standing support, enhancing functional independence and reducing pressure-related complications.
This device is intended for use in clinical, home, and rehabilitation settings and is supplied as a reusable, non-sterile product. It is regulated under FDA 510(k) clearance (K083017) and the EU Medical Device Regulation (MDR), with a primary application in physical medicine. Multiple model variants are available, as indicated by the associated FEI numbers, and it must be operated in compliance with manufacturer guidelines to ensure safe functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK083017 | Date24 Oct 2008 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Levo C3
- 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
Other devices from Levo AG
Questions
What settings can the Levo C3 Standup Wheelchair be used in, and how does it help users?
The Levo C3 Standup Wheelchair is designed for use in clinical, home, and rehabilitation environments. It assists individuals with physical disabilities by providing active standing support, enabling transitions between seated and standing positions. This feature enhances functional independence and helps reduce pressure-related complications, making it particularly useful for users who benefit from periodic standing to improve circulation and comfort.
Is the Levo C3 Standup Wheelchair single-use or reusable, and what does that mean for maintenance?
The Levo C3 Standup Wheelchair is supplied as a reusable device, meaning it is intended for repeated use by multiple patients. Since it is non-sterile, proper cleaning and maintenance per the manufacturer’s guidelines are required to ensure safe and hygienic operation between users. This includes regular inspections and servicing to maintain functionality and safety.
What model variants of the Levo C3 Standup Wheelchair are available, and how can I identify them?
The Levo C3 Standup Wheelchair comes in multiple model variants, each identified by unique FEI numbers. These include: 3014653196, 3004908349, 3014890685, 3010585416, 3001045529, 3019677893, 3023852281, 1000413464, 3014250398, 3007494904, 2937137, 3022115583, 1000268398, 1221084, 3003650116, and 3007923118. These variants may differ in specifications or features, so verifying the exact FEI number ensures compatibility with your needs.
How is the Levo C3 Standup Wheelchair regulated, and what does that mean for purchasing or prescribing it?
The Levo C3 Standup Wheelchair is regulated under both the FDA’s 510(k) clearance process (with clearance number K083017) and the EU Medical Device Regulation (MDR). The FDA classifies it as a Class II device under the Physical Medicine category, meaning it has undergone a review to ensure safety and effectiveness. For purchasing or prescribing, this means it meets established regulatory standards, but always verify compliance with local healthcare regulations and consult manufacturer guidelines for proper use.
How should the Levo C3 Standup Wheelchair be stored to maintain its performance and safety?
Since the Levo C3 is a reusable, non-sterile device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage also includes keeping it free from dust, moisture, and physical damage. Follow the manufacturer’s instructions for any specific storage recommendations to ensure the device remains functional and safe for repeated use.