510(k) · Cleared
ClearedLevo Mobil LCM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levo USA · IPL Wheelchair, Standup
Cleared on Dec 23, 1997 after a 456-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Dec 23, 1997
- Review
- 456 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 5 citing it directly.
- This deviceK963817 Levo Mobil LCMLevo USA · 1997
- Descendant · cites it directly · 9 of its ownK051387 Levo Comfort IILevo AG · 2005
- Descendant · cites it directly · 6 of its ownK030893 Levo CombiLevo AG · 2003
- Descendant · 2 generations on · 4 of its ownK083017 LEVO C3Levo AG · 2008
- Descendant · cites it directly · 3 of its ownK041535 LSC Lifestand CompactLifestand · 2004
- Descendant · 3 generations on · 2 of its ownK172384 Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K051387Levo Comfort IILevo AG · 2005 · cites it directly9descendants
- K030893Levo CombiLevo AG · 2003 · cites it directly6descendants
- K083017LEVO C3Levo AG · 2008 · 2 generations on4descendants
- K041535LSC Lifestand CompactLifestand · 2004 · cites it directly3descendants
- K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963817 | Levo Mobil LCM | Levo USA | 1997 | — |
| +1 | K051387 | Levo Comfort II | Levo AG | 2005 | — |
| +1 | K030893 | Levo Combi | Levo AG | 2003 | — |
| +2 | K083017 | LEVO C3 | Levo AG | 2008 | — |
| +1 | K041535 | LSC Lifestand Compact | Lifestand | 2004 | — |
| +3 | K172384 | Quickie (r) Q700-UP M | Sunrise Medical (Us), LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K051387 (Levo AG, 2005) has gone furthest, with 9 descendants of its own.
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 LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.
Target population:
For whole those who needs an electrical power wheelchair and can not stand on their on feet such as
- people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963817: Levo Mobil LCM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963817
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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