510(k) · Cleared
Recalled · Class I · 2025WHILL Model F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Whill, Inc. · ITI Wheelchair, Powered
Cleared on Jun 7, 2022 as substantially equivalent to K213383 (Whill, Inc., 2021) after a 21-day review. Its family tree reaches back 8 generations to 1997. 2 of the 10 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jun 7, 2022
- Review
- 21 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 8 generations to K960951 (1997). 9 ancestors in all. No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK960951 Permobil Chairman L/CS 8Permobil AB · 1997
- 7 generations backK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- 6 generations backK041219 ElectroPermobil AB · 2004 · Recalled
- 5 generations backK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- 4 generations backK103477 Permobil M300 / M400Permobil AB · 2011
- 3 generations backK143180 F3Permobil AB · 2015
- 2 generations backK153543 WHILL Model MWhill, Inc. · 2016
- 1 generation backK213383 WHILL Model C2Whill, Inc. · 2021 · Recalled (Class I)
- This deviceK221438 WHILL Model FWhill, Inc. · 2022
Class I recalls in this family
- K213383 WHILL Model C2direct predicate · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K960951 | Permobil Chairman L/CS 8 | Permobil AB | 1997 | — |
| −7 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| −6 | K041219 | Electro | Permobil AB | 2004 | 4 |
| −5 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| −4 | K103477 | Permobil M300 / M400 | Permobil AB | 2011 | — |
| −3 | K143180 | F3 | Permobil AB | 2015 | — |
| −2 | K153543 | WHILL Model M | Whill, Inc. | 2016 | — |
| −1 | K213383 | WHILL Model C2 | Whill, Inc. | 2021 | Class I |
| 0 (this device) | K221438 | WHILL Model F | Whill, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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.
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 |
|---|---|---|---|
| * | K213383 | WHILL Model C2Summary page 4…PREDICATE DEVICE Primary Predicate Device • Manufacturer: Whill, Inc. • Trade Name: WHILL Model C2 • 510(k): K213383 • Classification Name: Physical Medicine • Regulation: 21 CFR § 890.3860 • Regulator… | 2021 |
| † | K170787 | Powered Wheelchair DYW30A (D09) | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2025 | Class I | Z-1827-2026 | Device Design | Cyber vulnerability of BLE communication was found by CISA VDP program. |
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.
- K213383WHILL Model C2Whill, Inc. · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K213383.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 WHILL Model F powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
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/K221438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221438: WHILL Model F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221438
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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