510(k) · Cleared
ClearedSinon Power Wheelchair, SN-P401
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinon Corporation · ITI Wheelchair, Powered
Cleared on Mar 12, 2004 as substantially equivalent to K023148 (Emg Technology Co., Ltd., 2003) after a 32-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Mar 12, 2004
- Review
- 32 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023148 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
- This deviceK040320 Sinon Power Wheelchair, SN-P401Sinon Corporation · 2004
- Descendant · cites it directly · 0 of its ownK042719 Home Health Power Wheelchair, Model HC-200Home Health Technology Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK043376 Home Health Power Wheelchair, Model HC-200TRHome Health Technology Co., Ltd. · 2005
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 | K023148 | Epw Powered Wheelchair, GP-201 | Emg Technology Co., Ltd. | 2003 | — |
| 0 (this device) | K040320 | Sinon Power Wheelchair, SN-P401 | Sinon Corporation | 2004 | — |
| +1 | K042719 | Home Health Power Wheelchair, Model HC-200 | Home Health Technology Co., Ltd. | 2005 | — |
| +1 | K043376 | Home Health Power Wheelchair, Model HC-200TR | Home Health Technology Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K023148 | Epw Powered Wheelchair, GP-201Summary page 1…r, and their chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: EPW Power Wheelchair GP-201 (K023148) 1o '-/o3J r'~~SlNON CORPORA… | 2003 |
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?
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 device is in!ended for medical purposes to provide mobility to persons restricted to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040320 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040320: Sinon Power Wheelchair, SN-P401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040320
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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