510(k) · Cleared
ClearedLittle Wave Arc; Little Wave Flip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ki Mobility, LLC · LBE Stroller, Adaptive
Cleared on Aug 31, 2023 as substantially equivalent to K151492 (R82 A/S, 2016) after a 281-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Aug 31, 2023
- Review
- 281 days
- Class
- Class I
- Product code
- LBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151492 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK151492 KuduR82 A/S · 2016
- This deviceK223533 Little Wave Arc; Little Wave FlipKi Mobility, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151492 | Kudu | R82 A/S | 2016 | — |
| 0 (this device) | K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | 2023 | — |
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 LBE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K151492 | KuduSummary page 4…ber 890.3850 Product Code LBE I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K151492 R82 Kudu LBE Device Description Summary 21 CFR 807.92(a)(4) The Ki Mobility Little Wave Arc is used by pediatrics up to 165lb (… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K151492.
How does its category compare?
All LBE devicesLBE Stroller, Adaptive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LBE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LBE
Too few LBE 510(k)s in any year since 2007 to give a median.
Recalls per year · LBE
No recall names LBE since 2007.
Adverse event reports per year · LBE
1in 2025
MAUDE reports naming product code LBE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ki Mobility Little Wave Arc and Little Wave Flip 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/K223533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223533: Little Wave Arc; Little Wave Flip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223533
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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