# K042596: Lsa Helium

- Pathway: 510(k) (Traditional)
- Applicant: Lifestand
- Decided: Jan 26, 2005 after 125 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
Longest line of descent: 1 generation back to K971873 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971873: Levo Active-Easy Lae, Levo USA (1997) Summary page 2.

## Indications for use
The LSA Helium offers seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

Source page: https://510kreport.com/device/K042596
Methodology: https://510kreport.com/methodology