510(k) · Cleared
ClearedPower Standing Dani
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davismade, Inc. · IPL Wheelchair, Standup
Cleared on Jul 6, 2009 as substantially equivalent to K041535 (Lifestand, 2004) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 6, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963817 (1997). 3 ancestors in all, the oldest K890602 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963817 | Levo Mobil LCM | Levo USA | 1997 | — |
| −1 | K041535 | LSC Lifestand Compact | Lifestand | 2004 | — |
| 0 (this device) | K090256 | Power Standing Dani | Davismade, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 |
|---|---|---|---|
| * | K041535 | LSC Lifestand CompactSummary page 1…Electric Power Wheelchair, Stand-up Regulatory Class: Class II Product Code: IPL Identification of Predicate Devices: Lifestand - LSC Lifestand (K041535) DavisMade Standing Dani (K890602) Ulrich Alber e-fix… | 2004 |
| * | K890602 | Standing Dani WheelstandSummary page 1…II Product Code: IPL Identification of Predicate Devices: Lifestand - LSC Lifestand (K041535) DavisMade Standing Dani (K890602) Ulrich Alber e-fix ® power add-on (K041535)\ Intende… | 1989 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K041535.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Power Standing Dani stand-up wheelchair (wheelstand) is a sit to stand mobility device equipped a removable prone board and standing platform with a joystick controlled power driven rear mounted wheels, providing the pediatric population with disabilities the. assistive technology to, independently ambulate in the standing position. Types of disability diagnosis include spina bifida, cerebral palsy, muscular dystrophy, spinal muscular atrophy, spinal cord injury, and various other neurological disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090256: Power Standing Dani.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090256
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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