510(k) · Cleared
Recalled · Class II · 2018Electro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permobil AB · ITI Wheelchair, Powered
Cleared on Aug 4, 2004 as substantially equivalent to K991658 (Permobil AB, 1999) after an 86-day review. Its family tree reaches back 2 generations to 1997. 2 of the 26 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 4, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960951 (1997). 3 ancestors in all. 22 later devices descend from it, 1 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 1 generation backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- This deviceK041219 ElectroPermobil AB · 2004
- Descendant · cites it directly · 21 of its ownK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- Descendant · 2 generations on · 12 of its ownK103477 Permobil M300 / M400Permobil AB · 2011
- Descendant · 3 generations on · 9 of its ownK143180 F3Permobil AB · 2015
- Descendant · 4 generations on · 7 of its ownK153543 WHILL Model MWhill, Inc. · 2016
- Descendant · 5 generations on · 6 of its ownK213383 WHILL Model C2Whill, Inc. · 2021 · Recalled (Class I)
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K071650C350 Powered WheelchairPermobil AB · 2007 · cites it directly21descendants
- K103477Permobil M300 / M400Permobil AB · 2011 · 2 generations on12descendants
- K143180F3Permobil AB · 2015 · 3 generations on9descendants
- K153543WHILL Model MWhill, Inc. · 2016 · 4 generations on7descendants
- K213383WHILL Model C2Whill, Inc. · 2021 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −1 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| 0 (this device) | K041219 | Electro | Permobil AB | 2004 | — |
| +1 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| +2 | K103477 | Permobil M300 / M400 | Permobil AB | 2011 | — |
| +3 | K143180 | F3 | Permobil AB | 2015 | — |
| +4 | K153543 | WHILL Model M | Whill, Inc. | 2016 | — |
| +5 | K213383 | WHILL Model C2 | Whill, Inc. | 2021 | Class I |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 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? (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 |
|---|---|---|---|
| * | K991658 | Permobil Powered Wheelchair 1280Summary page 1…April 29, 2004 Device name: ELECTRO Classification Name: Powered wheelchair Predicate Devices: Chairman 2k (1280) (K991658) manufactured by Permobil AB. Intended use: The intended use of the ELECTRO powered wheelchair is to provid… | 1999 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071650 | C350 Powered Wheelchair | 2007 | 21 |
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. |
| Feb 21, 2012 | Not classified | Z-1278-2012 | Mixed-up of materials/components | The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment. |
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K071650 (Permobil AB, 2007) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K991658.
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 of the Electro series of the powered wheelchair is to provide
indoor and outdoor mobility to persons limited to a seating position that are
capable of operating a powered wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041219: Electro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041219
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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