510(k) · Cleared
Recalled · Class II · 2025M300 & M400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permobil AB · ITI Wheelchair, Powered
Cleared on Apr 17, 2013 as substantially equivalent to K071650 (Permobil AB, 2007) after a 177-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 17, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960951 (1997). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 3 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- 2 generations backK041219 ElectroPermobil AB · 2004 · Recalled
- 1 generation backK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- This deviceK123290 M300 & M400Permobil AB · 2013
- Descendant · cites it directly · 0 of its ownK202632 Electric wheelchair (S7204/S7205)Dongguan Prestige Sporting Goods Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK140706 Levo MaxLevo AG · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −3 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| −2 | K041219 | Electro | Permobil AB | 2004 | 4 |
| −1 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| 0 (this device) | K123290 | M300 & M400 | Permobil AB | 2013 | — |
| +1 | K202632 | Electric wheelchair (S7204/S7205) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021 | — |
| +1 | K140706 | Levo Max | Levo AG | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 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 ITI? 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 |
|---|---|---|---|
| * | K071650 | C350 Powered WheelchairSummary page 1…ame: M300 & M400 Classification Name; Powered wheelchair (21 CFR 890.3860, Product Code IT]) Predicate Devices: C350 (K07 1650) manufactured by Permobil AB. Intended use: The intended use of the M300 & M400 powered wheelchair is to pro… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2025 | Class II | Z-2805-2026 | Process design | This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain… |
| Feb 29, 2024 | Class II | Z-2795-2026 | Process control | This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over, |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K202632 (Dongguan Prestige Sporting Goods Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071650.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 M300 & M400 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/K123290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123290: M300 & M400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123290
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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