510(k) · Cleared
Recalled · Class II · 2026Quantum Blast
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 Jul 13, 2001 as substantially equivalent to K945936 (Pride Health Care, Inc., 1996) after a 17-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 13, 2001
- Review
- 17 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 3
- 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 deviceK011993 Quantum BlastPride Mobility Products Corp. · 2001
- Descendant · cites it directly · 0 of its ownK052353 Z-ChairPride Mobility Products Corp. · 2005
- Descendant · cites it directly · 0 of its ownK032765 StreetPermobil AB · 2004
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) | K011993 | Quantum Blast | Pride Mobility Products Corp. | 2001 | — |
| +1 | K052353 | Z-Chair | Pride Mobility Products Corp. | 2005 | — |
| +1 | K032765 | Street | Permobil AB | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 1…nit Classification Name: Power Wheel Chair Comparison to Predicate Devices: The product, which is substantially equivalent to the Quantum Blast, is the SC900 (Jazzy) (K945936) they both are Joystick controlled, with onboard batteries and battery charger. All safety features are equivalent. Device Descr… | 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-2844-2026 | 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-2853-2026 | 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… |
| 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 Quantum Blast is to provide mobility for persons limited to a seated position that are capable of operating a powered wheelchair.
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/K011993 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011993: Quantum Blast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011993
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026