510(k) · Cleared
ClearedTrax, Powered Wheelchair, Model 308686-00-0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Permobil AB · ITI Wheelchair, Powered
Cleared on Dec 18, 2000 as substantially equivalent to K870224 (Permobil of America, 1987) and 1 other predicate after a 437-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Dec 18, 2000
- Review
- 437 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K870224 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK870224 Permobil MaxiorPermobil of America · 1987
- This deviceK993406 Trax, Powered Wheelchair, Model 308686-00-0Permobil AB · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870224 | Permobil Maxior | Permobil of America | 1987 | — |
| 0 (this device) | K993406 | Trax, Powered Wheelchair, Model 308686-00-0 | Permobil AB | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 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? (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 |
|---|---|---|---|
| * | K870224 | Permobil MaxiorSummary page 1…50 Bengt Persson bengt.persson@permobil se September 30 1999 TRAX Classification name Powered wheelchair identification of predicate devices Intended use Max90 (K870224) Exterior (K870225) The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting positi… | 1987 |
| * | K870225 | Permobil ExteriorSummary page 1…bengt.persson@permobil se September 30 1999 TRAX Classification name Powered wheelchair identification of predicate devices Intended use Max90 (K870224) Exterior (K870225) The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting position. Description of… | 1987 |
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?
- None of the 2 ancestors has a recall.
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?
Powered wheelchair, battery-operated device w:lth wheels that is intended for medical purposes to provide indoor and outdoor mobility to persons restricted to a sitting position. Class IL. The indoor use is depending of available space.
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/K993406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993406: Trax, Powered Wheelchair, Model 308686-00-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993406
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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