510(k) · Cleared
Recalled · Class II · 2021Merits Model P322FWD Powered Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merits Health Products Co., Ltd. · ITI Wheelchair, Powered
Cleared on Jan 9, 2013 as substantially equivalent to K090108 (Hoveround Corp., 2009) after a 159-day review. Its family tree reaches back 1 generation to 2009. It has been recalled once.
- Decided
- Jan 9, 2013
- Review
- 159 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090108 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK090108 Hoveround Teknique FWD MK4 Power WheelchairHoveround Corp. · 2009
- This deviceK122357 Merits Model P322FWD Powered WheelchairMerits Health Products Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090108 | Hoveround Teknique FWD MK4 Power Wheelchair | Hoveround Corp. | 2009 | — |
| 0 (this device) | K122357 | Merits Model P322FWD Powered Wheelchair | Merits Health Products Co., Ltd. | 2013 | — |
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 |
|---|---|---|---|
| * | K090108 | Hoveround Teknique FWD MK4 Power WheelchairSummary page 1…ces: This submission indicates the Substantial Equivalence of Merits Model P322 FWD Powered Wheelchair with the predicate Hoveround Teknique FWD mk4 Power Chair (K090108). P322 has the same intended uses and similar indications, technological characteristics and principles of operation with p… | 2009 |
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 |
|---|---|---|---|---|
| Apr 1, 2021 | Class II | Z-1504-2021 | Process change control | Seat baseplate pin has broken in the field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122357: Merits Model P322FWD Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122357
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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