510(k) · Cleared
ClearedEpw Foldable Power Wheelchair, Epw-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emg Technology Co., Ltd. · ITI Wheelchair, Powered
Cleared on Dec 18, 2003 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 18, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK033206 Epw Foldable Power Wheelchair, Epw-03Emg Technology Co., Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK040319 Sinon Power Wheelchair, SN-W401Sinon Corporation · 2004
- Descendant · 2 generations on · 0 of its ownK050087 Lerado Avanticare Power Wheelchair, Model PW-1800Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
- Descendant · 2 generations on · 0 of its ownK041678 Karma Power Wheelchair, Model KP-25Karma Medical Products Co., Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK041336 Pro Walker PL-200 Power WheelchairPro Walker, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK041190 A&I Power Wheelchair, PC-401Well Success Biotech, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K040319Sinon Power Wheelchair, SN-W401Sinon Corporation · 2004 · cites it directly4descendants
- K050087Lerado Avanticare Power Wheelchair, Model PW-1800Lerado Oversea Ltd. Twn Branch (Bvi) · 2005 · 2 generations on0descendants
- K041678Karma Power Wheelchair, Model KP-25Karma Medical Products Co., Ltd. · 2004 · 2 generations on0descendants
- K041336Pro Walker PL-200 Power WheelchairPro Walker, Inc. · 2004 · 2 generations on0descendants
- K041190A&I Power Wheelchair, PC-401Well Success Biotech, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033206 | Epw Foldable Power Wheelchair, Epw-03 | Emg Technology Co., Ltd. | 2003 | — |
| +1 | K040319 | Sinon Power Wheelchair, SN-W401 | Sinon Corporation | 2004 | — |
| +2 | K050087 | Lerado Avanticare Power Wheelchair, Model PW-1800 | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| +2 | K041678 | Karma Power Wheelchair, Model KP-25 | Karma Medical Products Co., Ltd. | 2004 | — |
| +2 | K041336 | Pro Walker PL-200 Power Wheelchair | Pro Walker, Inc. | 2004 | — |
| +2 | 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 | 4 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040319 | Sinon Power Wheelchair, SN-W401 | 2004 | 4 |
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?
- Of its descendants, K040319 (Sinon Corporation, 2004) has gone furthest, with 4 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 510(k) statement.
https://510kreport.com/device/K033206 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033206: Epw Foldable Power Wheelchair, Epw-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033206
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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