510(k) · Cleared
ClearedSinon Power Wheelchair, SN-W401
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinon Corporation · ITI Wheelchair, Powered
Cleared on Feb 20, 2004 as substantially equivalent to K033206 (Emg Technology Co., Ltd., 2003) after an 11-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033206 (2003). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK033206 Epw Foldable Power Wheelchair, Epw-03Emg Technology Co., Ltd. · 2003
- This deviceK040319 Sinon Power Wheelchair, SN-W401Sinon Corporation · 2004
- Descendant · cites it directly · 0 of its ownK050087 Lerado Avanticare Power Wheelchair, Model PW-1800Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
- Descendant · cites it directly · 0 of its ownK041678 Karma Power Wheelchair, Model KP-25Karma Medical Products Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK041336 Pro Walker PL-200 Power WheelchairPro Walker, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK041190 A&I Power Wheelchair, PC-401Well Success Biotech, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K050087Lerado Avanticare Power Wheelchair, Model PW-1800Lerado Oversea Ltd. Twn Branch (Bvi) · 2005 · cites it directly0descendants
- K041678Karma Power Wheelchair, Model KP-25Karma Medical Products Co., Ltd. · 2004 · cites it directly0descendants
- K041336Pro Walker PL-200 Power WheelchairPro Walker, Inc. · 2004 · cites it directly0descendants
- K041190A&I Power Wheelchair, PC-401Well Success Biotech, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033206 | Epw Foldable Power Wheelchair, Epw-03 | Emg Technology Co., Ltd. | 2003 | — |
| 0 (this device) | K040319 | Sinon Power Wheelchair, SN-W401 | Sinon Corporation | 2004 | — |
| +1 | K050087 | Lerado Avanticare Power Wheelchair, Model PW-1800 | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| +1 | K041678 | Karma Power Wheelchair, Model KP-25 | Karma Medical Products Co., Ltd. | 2004 | — |
| +1 | K041336 | Pro Walker PL-200 Power Wheelchair | Pro Walker, Inc. | 2004 | — |
| +1 | K041190 | A&I Power Wheelchair, PC-401 | Well Success Biotech, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 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 |
|---|---|---|---|
| * | K033206 | Epw Foldable Power Wheelchair, Epw-03Summary page 1…ers - requirements and test methods) Legally marketed device for substantial equivalence comparison: EPW Foldable Power Wheelchair EPW-03 (K033206) DI… | 2003 |
What descends from it? (4)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K050087 (Lerado Oversea Ltd. Twn Branch (Bvi), 2005) has gone furthest, with 0 descendants of its own.
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 intended 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/K040319 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040319: Sinon Power Wheelchair, SN-W401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040319
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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