510(k) · Cleared
Recalled · Class II · 2016Synergy Ultimate
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 Sep 8, 2004 after a 111-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Sep 8, 2004
- Review
- 111 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Motion Concept's TRX-CG Power Positioning System with Center-of Gravity Shifting Power… Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2016 | Class II | Z-0942-2017 | Use error | The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle. |
No ancestor or descendant has a Class I recall.
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 Pride Mobility Products Corp. Synergy Ultimate is a power positioning seating system designed for users who need to operate their power chair and seating system independently without assistance from an attendant. The user is able to adjust the unit to achieve comfort, pressure relief, and necessary repositioning. The Synergy Ultimate is available with any or all of the following features: Power Tilt, Power-Elevating Seat, Power Recline, and Power…
Read the full statement (125 words)
The Pride Mobility Products Corp. Synergy Ultimate is a
power positioning seating system designed for users who need to operate their
power chair and seating system independently without assistance from an
attendant. The user is able to adjust the unit to achieve comfort, pressure relief,
and necessary repositioning.
The Synergy Ultimate is available with any or all of the following features: Power
Tilt, Power-Elevating Seat, Power Recline, and Power Elevating Leg rests. All
functions can be controlled from the user's joystick, through an attendant control
device, or through an optional toggle switch.
Pride Mobility Products Corp. makes no claims as to the therapeutic
effectiveness of the product listed above. Pride Mobility Products Corp. strongly
recommends a certified rehabilitation therapist evaluate all customers of its
products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041346 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041346: Synergy Ultimate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041346
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026