510(k) · Cleared
ClearedParaMotion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Powerbasetec GmbH · IPL Wheelchair, Standup
Cleared on Jan 21, 2022 as substantially equivalent to K060936 (Parabasetec, GmbH, 2006) after a 394-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jan 21, 2022
- Review
- 394 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963817 (1997). 4 ancestors in all. 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 |
|---|---|---|---|---|---|
| −3 | K963817 | Levo Mobil LCM | Levo USA | 1997 | — |
| −2 | K051387 | Levo Comfort II | Levo AG | 2005 | — |
| −1 | K060936 | Paragolfer | Parabasetec, GmbH | 2006 | — |
| 0 (this device) | K203761 | ParaMotion | Powerbasetec GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 K190682 Explorer Miniscore -1.1 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K060936 | ParagolferSummary page 5…890.3900 Product Code IPL Device Class II Review Panel Physical Medicine 510(k) number K060936 Clearance August 07, 2006 Subject Device Description The ParaMotion is an all-terrain electric wheelchai… | 2006 |
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 25 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio
any individual to take part in sports activities requiring an upright position
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203761: ParaMotion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203761
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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