510(k) · Cleared
ClearedQuickie G Series, Model G-424
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical, Inc. · ITI Wheelchair, Powered
Cleared on Nov 6, 1998 after an 18-day review. The FDA summary names its predicate without a number. 2 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 18 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 1 citing it directly. 2 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK983677 Quickie G Series, Model G-424Sunrise Medical, Inc. · 1998
- Descendant · cites it directly · 32 of its ownK991658 Permobil Powered Wheelchair 1280Permobil AB · 1999 · Recalled
- Descendant · 2 generations on · 22 of its ownK041219 ElectroPermobil AB · 2004 · Recalled
- Descendant · 3 generations on · 21 of its ownK071650 C350 Powered WheelchairPermobil AB · 2007 · Recalled
- Descendant · 4 generations on · 12 of its ownK103477 Permobil M300 / M400Permobil AB · 2011
- Descendant · 5 generations on · 9 of its ownK143180 F3Permobil AB · 2015
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K991658Permobil Powered Wheelchair 1280Permobil AB · 1999 · cites it directly32descendants
- K041219ElectroPermobil AB · 2004 · 2 generations on22descendants
- K071650C350 Powered WheelchairPermobil AB · 2007 · 3 generations on21descendants
- K103477Permobil M300 / M400Permobil AB · 2011 · 4 generations on12descendants
- K143180F3Permobil AB · 2015 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983677 | Quickie G Series, Model G-424 | Sunrise Medical, Inc. | 1998 | — |
| +1 | K991658 | Permobil Powered Wheelchair 1280 | Permobil AB | 1999 | 5 |
| +2 | K041219 | Electro | Permobil AB | 2004 | 4 |
| +3 | K071650 | C350 Powered Wheelchair | Permobil AB | 2007 | 3 |
| +4 | K103477 | Permobil M300 / M400 | Permobil AB | 2011 | — |
| +5 | K143180 | F3 | Permobil AB | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 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? (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 |
|---|---|---|---|
| * | — | Quickie P200 Named without a submission number | |
| * | — | Quickie P120 Named without a submission number |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991658 | Permobil Powered Wheelchair 1280 | 1999 | 32 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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?
- Of its descendants, K991658 (Permobil AB, 1999) has gone furthest, with 32 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.
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?
Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility
This includes conditions in all ages such as:
Arthritis Head Injury or Trauma
Amputee Muscular Dystrophy
Paraplegic Multiple Sclerosts
Cerebral Palsy Polio
Hemiplegic Geriatric Conditions
Tetraplegic (Quadraplegic) And other immobilizing or debilitating conditions
Spina Bifida
A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249
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/K983677 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983677: Quickie G Series, Model G-424.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983677
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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