510(k) · Cleared
ClearedEpw Powered Wheelchair, GP-201
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 Jan 24, 2003 after a 126-day review. The FDA summary names no predicate by number. 82 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 126 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
82 later devices descend from it, 2 citing it directly.
- This deviceK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
- Descendant · cites it directly · 78 of its ownK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
- Descendant · 2 generations on · 73 of its ownK070501 Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007
- Descendant · 3 generations on · 71 of its ownK113463 Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012
- Descendant · 4 generations on · 37 of its ownK220747 Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- Descendant · 5 generations on · 8 of its ownK231508 Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K062888Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006 · cites it directly78descendants
- K070501Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007 · 2 generations on73descendants
- K113463Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012 · 3 generations on71descendants
- K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 4 generations on37descendants
- K231508Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023148 | Epw Powered Wheelchair, GP-201 | Emg Technology Co., Ltd. | 2003 | — |
| +1 | K062888 | Middle Wheel Drive Power Chair, CWD01 | Emg Technology Co., Ltd. | 2006 | — |
| +2 | K070501 | Ruike 3421 Powered Wheelchair | Shanghai Ruike Sports Goods Co., Ltd. | 2007 | — |
| +3 | K113463 | Power Wheelchair | Suzhou KD Medical Appliance Co., Ltd. | 2012 | — |
| +4 | K220747 | Power Wheelchair (N5515B) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| +5 | K231508 | Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 24 | 0 |
| 2025 | 20 | 0 |
| 2026 | 14 | 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?
The FDA summary names no predicate by number.
What descends from it? (82)
See all 822 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?
- Of its descendants, K062888 (Emg Technology Co., Ltd., 2006) has gone furthest, with 78 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/K023148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023148: Epw Powered Wheelchair, GP-201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023148
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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