510(k) · Cleared
Recalled · Class II · 2018C350 Powered Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permobil AB · ITI Wheelchair, Powered
Cleared on Sep 12, 2007 as substantially equivalent to K041219 (Permobil AB, 2004) after an 86-day review. Its family tree reaches back 3 generations to 1997. 2 of the 26 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 12, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960951 (1997). 4 ancestors in all. 21 later devices descend from it, 4 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 2 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- 1 generation backK041219 ElectroPermobil AB · 2004 · Recalled
- This deviceK071650 C350 Powered WheelchairPermobil AB · 2007
- Descendant · cites it directly · 12 of its ownK103477 Permobil M300 / M400Permobil AB · 2011
- Descendant · 2 generations on · 9 of its ownK143180 F3Permobil AB · 2015
- Descendant · 3 generations on · 7 of its ownK153543 WHILL Model MWhill, Inc. · 2016
- Descendant · 4 generations on · 6 of its ownK213383 WHILL Model C2Whill, Inc. · 2021 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK083017 LEVO C3Levo AG · 2008
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K103477Permobil M300 / M400Permobil AB · 2011 · cites it directly12descendants
- K143180F3Permobil AB · 2015 · 2 generations on9descendants
- K153543WHILL Model MWhill, Inc. · 2016 · 3 generations on7descendants
- K213383WHILL Model C2Whill, Inc. · 2021 · 4 generations on6descendants
- K083017LEVO C3Levo AG · 2008 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −2 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| −1 | K041219 | Electro | Permobil AB | 2004 | 4 |
| 0 (this device) | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | — |
| +1 | K103477 | Permobil M300 / M400 | Permobil AB | 2011 | — |
| +2 | K143180 | F3 | Permobil AB | 2015 | — |
| +3 | K153543 | WHILL Model M | Whill, Inc. | 2016 | — |
| +4 | K213383 | WHILL Model C2 | Whill, Inc. | 2021 | Class I |
| +1 | K083017 | LEVO C3 | Levo AG | 2008 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K041219 | ElectroSummary page 1…ed: June, 2007 Device name: C350 Classification Name: Powered wheelchair Predicate Devices: C300(Electro)( 1(041219) manufactured by Permobil AR Intended use: The intended use of the C350 powered wheelchair is to provide… | 2004 |
What descends from it? (21)
See all 214 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. |
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 10 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K103477 (Permobil AB, 2011) has gone furthest, with 12 descendants of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 C350 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/K071650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071650: C350 Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071650
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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