510(k) · Cleared
ClearedLsa Helium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifestand · IPL Wheelchair, Standup
Cleared on Jan 26, 2005 as substantially equivalent to K971873 (Levo USA, 1997) after a 125-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 26, 2005
- Review
- 125 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971873 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971873 Levo Active-Easy LaeLevo USA · 1997
- This deviceK042596 Lsa HeliumLifestand · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971873 | Levo Active-Easy Lae | Levo USA | 1997 | — |
| 0 (this device) | K042596 | Lsa Helium | Lifestand | 2005 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IPL device
- #1 K203761 ParaMotionscore 3.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971873 | Levo Active-Easy LaeSummary page 2…Comparison to Predicate Devices: The LSA Helium is substantially equivalent to the standup wheelchair LAE (ILEVO Active Easy) by LEVO, K971873 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPL
105in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPL
No recall names IPL since 2007.
Adverse event reports per year · IPL
5in 2025
MAUDE reports naming product code IPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 63 | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 3 | 105 | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042596: Lsa Helium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042596
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026