510(k) · Cleared
ClearedLevo Comfort II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levo AG · IPL Wheelchair, Standup
Cleared on Jun 10, 2005 as substantially equivalent to K963817 (Levo USA, 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- Jun 10, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963817 (1997). 2 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK963817 Levo Mobil LCMLevo USA · 1997
- This deviceK051387 Levo Comfort IILevo AG · 2005
- 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 · cites it directly · 1 of its ownK060936 ParagolferParabasetec, GmbH · 2006
- Descendant · 3 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 ownK203761 ParaMotionPowerbasetec GmbH · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083017LEVO C3Levo AG · 2008 · cites it directly4descendants
- K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018 · 2 generations on2descendants
- K060936ParagolferParabasetec, GmbH · 2006 · cites it directly1descendant
- K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024 · 3 generations on0descendants
- K203761ParaMotionPowerbasetec GmbH · 2022 · 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) | K051387 | Levo Comfort II | Levo AG | 2005 | — |
| +1 | K083017 | LEVO C3 | Levo AG | 2008 | — |
| +2 | K172384 | Quickie (r) Q700-UP M | Sunrise Medical (Us), LLC | 2018 | — |
| +1 | K060936 | Paragolfer | Parabasetec, GmbH | 2006 | — |
| +3 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | 2024 | — |
| +2 | K203761 | ParaMotion | Powerbasetec GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 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? (2)
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…r(Oevo.ch Device Name: LEVO com/forl]I Classification Name: Electrical Power Wheelchair, Stand-up Identification of Predicate Devices: LEVO mobil LCM (K 963817) Quickie Freestyle (K 031289) Intended Use: The LEVO comfort II stand-up power wheelchair is a pr… | 1997 |
| * | K031289 | Quickie Freestyle Power Wheelchair, Model G-424Summary page 1…Classification Name: Electrical Power Wheelchair, Stand-up Identification of Predicate Devices: LEVO mobil LCM (K 963817) Quickie Freestyle (K 031289) Intended Use: The LEVO comfort II stand-up power wheelchair is a product which changes people's p… | 2003 |
What descends from it? (9)
4 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 comfort H stand-up power wheelchair may be of interest for any individuals who needs a power wheelchair and can not 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/K051387 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051387: Levo Comfort II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051387
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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