510(k) · Cleared
ClearedLittle Wave Clik, Rogue XP, Little Wave XP, Spark
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ki Mobility, LLC · IOR Wheelchair, Mechanical
Cleared on Aug 31, 2023 as substantially equivalent to K983639 (Sunrise Medical, Inc., 1998) after a 281-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Aug 31, 2023
- Review
- 281 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983639 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983639 Zippie GS, Model # EizgsSunrise Medical, Inc. · 1998
- This deviceK223527 Little Wave Clik, Rogue XP, Little Wave XP, SparkKi Mobility, LLC · 2023
- Descendant · cites it directly · 0 of its ownK260295 Helio Kids; Apex PMotion Composites · 2026
- Descendant · cites it directly · 0 of its ownK250576 Flexx Junior (FLX-J00, FLX-J50)Karma Mobility Co, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983639 | Zippie GS, Model # Eizgs | Sunrise Medical, Inc. | 1998 | — |
| 0 (this device) | K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | 2023 | — |
| +1 | K260295 | Helio Kids; Apex P | Motion Composites | 2026 | — |
| +1 | K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K983639 | Zippie GS, Model # EizgsSummary page 4…mber 890.3850 Product Code IOR I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K983639 Zippie GS IOR Device Description Summary 21 CFR 807.92(a)(4) The Ki Mobility Little Wave Clik manual wheelchair is intended to p… | 1998 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K260295 (Motion Composites, 2026) has gone furthest, with 0 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. 2023, 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 Ki Mobility Little Wave Clik, Rogue XP, Little Wave XP, and Spark manual wheelchairs are intended to provide
mobility to pediatrics limited to a seating position.
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/K223527 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223527: Little Wave Clik, Rogue XP, Little Wave XP, Spark.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223527
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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