510(k) · Cleared
Recalled · Class II · 2026JAZZY 600
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 6, 2004 as substantially equivalent to K945936 (Pride Health Care, Inc., 1996) after a 12-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 6, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945936 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945936 JAZZYPride Health Care, Inc. · 1996 · Recalled
- This deviceK042612 JAZZY 600Pride Mobility Products Corp. · 2004
- Descendant · cites it directly · 0 of its ownK143383 Q6 Edge EMPride Mobility Product Corporation · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK142027 888 Wnle Powered WheelchairPihsiang Machinery Mfg. Co., Ltd. · 2014
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 | K945936 | JAZZY | Pride Health Care, Inc. | 1996 | 1 |
| 0 (this device) | K042612 | JAZZY 600 | Pride Mobility Products Corp. | 2004 | — |
| +1 | K143383 | Q6 Edge EM | Pride Mobility Product Corporation | 2015 | 7 |
| +1 | K142027 | 888 Wnle Powered Wheelchair | Pihsiang Machinery Mfg. Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 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 |
|---|---|---|---|
| * | K945936 | JAZZYSummary page 4…Name: Physical Medicine / Wheelchair, Powered Product Code: I Comparison to Predicate Devices: The Jazzy 600 is substantially equivalent to the Pride Mobility Jazzy (K945936) when comparing performance, maneuverability, stability, dimensions, and geometry. The performance characteristics and the positi… | 1996 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2026 | Class II | Z-2845-2026 | Under Investigation by firm | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop… |
| Jun 25, 2026 | Class II | Z-2846-2026 | Under Investigation by firm | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop… |
| Feb 1, 2010 | Not classified | Z-2619-2010 | Other | Improper set-up of the wire harness can allow wires to be pulled from their intended position and become caught under the motor mounting bracket located under the powered wheelchair. This can cause the wire connector and/or the wire… |
| Apr 11, 2008 | Not classified | Z-1776-2008 | Software design | Software - Watch dog timer feature was disabled. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Corp. Jazzy 600 Powered Wheelchair is to provide mobility to persons limited to a seated 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/K042612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042612: JAZZY 600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042612
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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