510(k) · Cleared
Recalled · Class II · 2016Quickie & Zippie Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical · IOR Wheelchair, Mechanical
Cleared on Aug 16, 2013 after a 233-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 16, 2013
- Review
- 233 days
- Class
- Class I
- Product code
- IOR
- Recalls
- 5
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK123975 Quickie & Zippie SeriesSunrise Medical · 2013
- Descendant · cites it directly · 3 of its ownK161425 APEX Manual WheelchairMotion Composites · 2016
- Descendant · 2 generations on · 1 of its ownK243111 Bowhead ERA WheelchairsBowhead Design Corp. · 2025
- Descendant · cites it directly · 1 of its ownK143101 Helio A7 Manual Wheelchair, Move Manual WheelchairMotion Composites · 2015
- Descendant · 2 generations on · 0 of its ownK260295 Helio Kids; Apex PMotion Composites · 2026
- Descendant · 3 generations on · 0 of its ownK260121 Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161425APEX Manual WheelchairMotion Composites · 2016 · cites it directly3descendants
- K243111Bowhead ERA WheelchairsBowhead Design Corp. · 2025 · 2 generations on1descendant
- K143101Helio A7 Manual Wheelchair, Move Manual WheelchairMotion Composites · 2015 · cites it directly1descendant
- K260295Helio Kids; Apex PMotion Composites · 2026 · 2 generations on0descendants
- K260121Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123975 | Quickie & Zippie Series | Sunrise Medical | 2013 | — |
| +1 | K161425 | APEX Manual Wheelchair | Motion Composites | 2016 | — |
| +2 | K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025 | — |
| +1 | K143101 | Helio A7 Manual Wheelchair, Move Manual Wheelchair | Motion Composites | 2015 | — |
| +2 | K260295 | Helio Kids; Apex P | Motion Composites | 2026 | — |
| +3 | K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
4 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 |
|---|---|---|---|---|
| Jul 1, 2016 | Class II | Z-2290-2016 | Device Design | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. |
| Jul 27, 2015 | Class II | Z-2467-2015 | Device Design | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. |
| Jul 27, 2015 | Class II | Z-2466-2015 | Device Design | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. |
| Dec 19, 2014 | Class II | Z-1020-2015 | Device Design | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. |
| Nov 11, 2013 | Class II | Z-0453-2014 | Nonconforming Material/Component | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161425 (Motion Composites, 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123975: Quickie & Zippie Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123975
Report an extraction error
Are you the manufacturer?
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