510(k) · Cleared
ClearedZippie GS, Model # Eizgs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical, Inc. · IOR Wheelchair, Mechanical
Cleared on Oct 25, 1998 after a 9-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 25, 1998
- Review
- 9 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK983639 Zippie GS, Model # EizgsSunrise Medical, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK223527 Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK260295 Helio Kids; Apex PMotion Composites · 2026
- Descendant · 2 generations on · 0 of its ownK250576 Flexx Junior (FLX-J00, FLX-J50)Karma Mobility Co, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983639 | Zippie GS, Model # Eizgs | Sunrise Medical, Inc. | 1998 | — |
| +1 | K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | 2023 | — |
| +2 | K260295 | Helio Kids; Apex P | Motion Composites | 2026 | — |
| +2 | K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (5)
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 Kidz Named without a submission number | |
| * | — | Zippie Named without a submission number | |
| * | — | Zippie 2 Named without a submission number | |
| * | — | Action Allegro Named without a submission number | |
| * | — | Action Comet Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | 2023 | 2 |
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?
- Of its descendants, K223527 (Ki Mobility, LLC, 2023) has gone furthest, with 2 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.
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?
Quickie manual wheelchairs empower physically challenged persons by providing a
means of mobility. This includes temporary and permanent conditions in all ages such
as:
Arthritis Tetraplegic Multiple Sclerosis
Amputee Quadriplegic Polio
Paraplegic Spina Bifida Geriatric conditions
Cerebral Palsy Head Injury or Trauma And other immobilizing or debilitating
conditions
A wheelchair 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 J2249
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/K983639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983639: Zippie GS, Model # Eizgs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983639
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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