# K973951: Levo Compact-Easy Lce

- Pathway: 510(k) (Traditional)
- Applicant: Levo USA
- Decided: Dec 23, 1997 after 68 days
- Product code: IPL (Wheelchair, Standup)
- Device class: 2
- Regulation: 21 CFR 890.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The LEVO stand-up wheelchair is a product which changes peoples position from seating to standing and standing to seating. Target population: * For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord i injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.. Design: * An electrical power suported stand-up mechanism is integrated in a manual driven wheelchair which allows the user (o stand up easilv when and where ever he wants to. Material: * Main frame: Colour painted aluminium. * Major stressed parts: Reinforced brass casting. * Upholstery: Flame impeded. * Batterv: 2 Gel, sealed lead acid battery (12V/2.9Ah in series=24V/2.9Ah) * Stand-up motor: Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N Performance: * The LEVO compact-easy LCE allows the user to stand up easily when and where ever he wants to. Whether to reach things without help of others, whether take part in discussions standing up and show infleence, whether Just to do daily therapy individually.

Source page: https://510kreport.com/device/K973951
Methodology: https://510kreport.com/methodology