510(k) · Cleared
ClearedLevo Combi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levo AG · IPL Wheelchair, Standup
Cleared on Apr 2, 2003 as substantially equivalent to K963817 (Levo USA, 1997) after a 12-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.
- Decided
- Apr 2, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963817 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963817 Levo Mobil LCMLevo USA · 1997
- This deviceK030893 Levo CombiLevo AG · 2003
- Descendant · cites it directly · 4 of its ownK083017 LEVO C3Levo AG · 2008
- Descendant · 2 generations on · 2 of its ownK172384 Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018
- Descendant · 3 generations on · 0 of its ownK233877 XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024
- Descendant · 3 generations on · 0 of its ownK191874 F5 Corpus VSPermobil AB · 2019
- Descendant · 2 generations on · 0 of its ownK191376 Modular Power Standing SystemMotion Concepts · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083017LEVO C3Levo AG · 2008 · cites it directly4descendants
- K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018 · 2 generations on2descendants
- K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024 · 3 generations on0descendants
- K191874F5 Corpus VSPermobil AB · 2019 · 3 generations on0descendants
- K191376Modular Power Standing SystemMotion Concepts · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963817 | Levo Mobil LCM | Levo USA | 1997 | — |
| 0 (this device) | K030893 | Levo Combi | Levo AG | 2003 | — |
| +1 | K083017 | LEVO C3 | Levo AG | 2008 | — |
| +2 | K172384 | Quickie (r) Q700-UP M | Sunrise Medical (Us), LLC | 2018 | — |
| +3 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | 2024 | — |
| +3 | K191874 | F5 Corpus VS | Permobil AB | 2019 | — |
| +2 | K191376 | Modular Power Standing System | Motion Concepts | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
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 |
|---|---|---|---|
| * | K963817 | Levo Mobil LCMSummary page 1…fischer@levo .ch Device Name: LEVO cornbi Classification Name: Electrical Power. Wheelchair, Stand-up LEVO inobil LCM (K 9638 17) Indtended Use: The LEVO coiiibi stand-up electrical power wheelchair is a product which changes peop… | 1997 |
What descends from it? (6)
2 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?
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 coinbi stand-up electrical power wheelchair is a product which changes pec?p!es pesitien m t only &om sitting to staiidiiig aiid standing io sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030893: Levo Combi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030893
Report an extraction error
Are you the manufacturer?
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