510(k) · Cleared
ClearedLEVO C3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levo AG · IPL Wheelchair, Standup
Cleared on Oct 24, 2008 as substantially equivalent to K030893 (Levo AG, 2003) and 2 other predicates after a 15-day review. Its family tree reaches back 4 generations to 1997. 4 later devices descend from it.
- Decided
- Oct 24, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960951 (1997). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 3 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- 2 generations backK041219 ElectroPermobil AB · 2004 · Recalled
- 1 generation backK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- This deviceK083017 LEVO C3Levo AG · 2008
- Descendant · cites it directly · 2 of its ownK172384 Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018
- Descendant · 2 generations on · 0 of its ownK233877 XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024
- Descendant · 2 generations on · 0 of its ownK191874 F5 Corpus VSPermobil AB · 2019
- Descendant · cites it directly · 0 of its ownK191376 Modular Power Standing SystemMotion Concepts · 2019
Most influential descendants
Showing 4 of 4 · See all- K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018 · cites it directly2descendants
- K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024 · 2 generations on0descendants
- K191874F5 Corpus VSPermobil AB · 2019 · 2 generations on0descendants
- K191376Modular Power Standing SystemMotion Concepts · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −3 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| −2 | K041219 | Electro | Permobil AB | 2004 | 4 |
| −1 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| 0 (this device) | K083017 | LEVO C3 | Levo AG | 2008 | — |
| +1 | K172384 | Quickie (r) Q700-UP M | Sunrise Medical (Us), LLC | 2018 | — |
| +2 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | 2024 | — |
| +2 | K191874 | F5 Corpus VS | Permobil AB | 2019 | — |
| +1 | K191376 | Modular Power Standing System | Motion Concepts | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K030893 | Levo CombiSummary page 1…ch Device Name: LEVO C 3 Classification Name: Electrical Power Wheelchair, Stand-up Identification of Predicate Devices: LEVO combi (K 030893) LEVO comfort II (K051387) Permobil C350 PS (K 071650) Intended… | 2003 |
| * | K051387 | Levo Comfort IISummary page 1…on Name: Electrical Power Wheelchair, Stand-up Identification of Predicate Devices: LEVO combi (K 030893) LEVO comfort II (K051387) Permobil C350 PS (K 071650) Intended Use: The LEVO C3 power wheelchair is a p… | 2005 |
| * | K071650 | C350 Powered WheelchairSummary page 1…tion of Predicate Devices: LEVO combi (K 030893) LEVO comfort II (K051387) Permobil C350 PS (K 071650) Intended Use: The LEVO C3 power wheelchair is a product which changes people's position in/from seating or/to… | 2007 |
What descends from it? (4)
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K172384 (Sunrise Medical (Us), LLC, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K030893.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 C3 power wheelchair with optional seating and standing position function may be of interest for any individuals who needs a power wheelchair and cannot stand up on their own such as 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/K083017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083017: LEVO C3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083017
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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