510(k) · Cleared
Recalled · Class II · 2018Permobil Powered Wheelchair 1280
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permobil AB · ITI Wheelchair, Powered
Cleared on Oct 8, 1999 as substantially equivalent to K960951 (Permobil AB, 1997) and 1 other predicate after a 147-day review. Its family tree reaches back 1 generation to 1997. 2 of the 35 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 8, 1999
- Review
- 147 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960951 (1997). 2 ancestors in all. 32 later devices descend from it, 2 citing it directly. 2 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- This deviceK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999
- Descendant · cites it directly · 22 of its ownK041219 ElectroPermobil AB · 2004 · Recalled
- Descendant · 2 generations on · 21 of its ownK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- Descendant · 3 generations on · 12 of its ownK103477 Permobil M300 / M400Permobil AB · 2011
- Descendant · 4 generations on · 9 of its ownK143180 F3Permobil AB · 2015
- Descendant · cites it directly · 8 of its ownK021264 TRZ-CG Power Positioning System with Center-of-Gravity Shifting…Motion Concepts · 2002
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 32 · See all- K041219ElectroPermobil AB · 2004 · cites it directly22descendants
- K071650C350 Powered WheelchairPermobil AB · 2007 · 2 generations on21descendants
- K103477Permobil M300 / M400Permobil AB · 2011 · 3 generations on12descendants
- K143180F3Permobil AB · 2015 · 4 generations on9descendants
- K021264TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline, and…Motion Concepts · 2002 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| 0 (this device) | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | — |
| +1 | K041219 | Electro | Permobil AB | 2004 | 4 |
| +2 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| +3 | K103477 | Permobil M300 / M400 | Permobil AB | 2011 | — |
| +4 | K143180 | F3 | Permobil AB | 2015 | — |
| +1 | K021264 | TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt… | Motion Concepts | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 1 |
| 2022 | 2 | 1 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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.
2 devices in this family have a Class I recall. 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K960951 | Permobil Chairman L/CS 8Summary page 1…@permobil.se May 10 1999 Powered wheelchair 1280 Classification name Powered wheelchair Identification of predicate devices Intended use Permobil Chairman L/CS 8 (K960951) G-424 power wheelchair (K983677) The intended use of Permobil powered wheelchair 1280 is to provide indoor and outdoor mobility… | 1997 |
| * | K983677 | Quickie G Series, Model G-424Summary page 1…d wheelchair 1280 Classification name Powered wheelchair Identification of predicate devices Intended use Permobil Chairman L/CS 8 (K960951) G-424 power wheelchair (K983677) The intended use of Permobil powered wheelchair 1280 is to provide indoor and outdoor mobility to persons restricted to a sitti… | 1998 |
What descends from it? (32)
See all 322 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2018 | Class II | Z-3178-2018 | Device Design | This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury. |
| Sep 1, 2017 | Class II | Z-0005-2018 | Device Design | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. |
| Sep 1, 2017 | Class II | Z-0006-2018 | Device Design | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. |
| Mar 7, 2003 | Not classified | Z-0834-03 | Other | One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair. |
| Jan 1, 2003 | Not classified | Z-0671-03 | Other | Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The intended use is to provide indoor and outdoor moblhty to persons restricted to a sitting 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/K991658 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991658: Permobil Powered Wheelchair 1280.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991658
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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