510(k) · Cleared
Recalled · Class II · 13Powerstand Stand-UP Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Standing Co., Inc. · IPL Wheelchair, Standup
Cleared on Jan 22, 2004 after a 198-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jan 22, 2004
- Review
- 198 days
- Class
- Class II
- Product code
- IPL
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 13 | Class II | Z-0993-2014 | Component design/selection | Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is… |
No ancestor or descendant has a Class I recall.
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 Powerstand Standing Wheelchair in indicated, BY PRESCRIPTION ONLY,
for users who have had, or may have in the future, positioning disorders relating
to paralysis, paresis or general weakness. The Powerstand Standing Wheelchair
helps users with mobility.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032101: Powerstand Stand-UP Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032101
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026