510(k) · Cleared
ClearedJazzy Frontie
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pride Mobility Products Corp. · ITI Wheelchair, Powered
Cleared on Oct 23, 2009 as substantially equivalent to K001970 (Pride Mobility Products Corp., 2000) after a 28-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Oct 23, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001970 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001970 Jet 1 Powered WheelchairPride Mobility Products Corp. · 2000 · Recalled
- This deviceK092961 Jazzy FrontiePride Mobility Products Corp. · 2009
- Descendant · cites it directly · 0 of its ownK113488 Jazzy Elite 6Pride Mobility Product Corporration · 2012
- Descendant · cites it directly · 0 of its ownK112815 Quantum Bariatric 451Pride Mobility Product Corporration · 2012 · Recalled
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 | K001970 | Jet 1 Powered Wheelchair | Pride Mobility Products Corp. | 2000 | 1 |
| 0 (this device) | K092961 | Jazzy Frontie | Pride Mobility Products Corp. | 2009 | — |
| +1 | K113488 | Jazzy Elite 6 | Pride Mobility Product Corporration | 2012 | — |
| +1 | K112815 | Quantum Bariatric 451 | Pride Mobility Product Corporration | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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.
Planning a device in ITI? 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? (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 |
|---|---|---|---|
| * | K001970 | Jet 1 Powered WheelchairSummary page 1…hysical Medicine / Powered Wheelchair Product Code: ITI Comparison to Predicate Devices: Pride Mobility Jet I (K001970), The Jazzy Frontie is substantially equivalent to the and structure.… | 2000 |
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 a recall.
- Of its descendants, K113488 (Pride Mobility Product Corporration, 2012) has gone furthest, with 0 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. 2009, this device’s year, is highlighted.
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?
The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092961 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092961: Jazzy Frontie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092961
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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