510(k) · Cleared
ClearedElectric Wheelchair (GY-E001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Guyue Healthcare Appliance Co., Ltd. · ITI Wheelchair, Powered
Cleared on Sep 9, 2025 as substantially equivalent to K240913 (Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd, 2024) after an 81-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Sep 9, 2025
- Review
- 81 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K023148 (2003). No later device cites it as a predicate yet.
- Root · 6 generations backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
- 5 generations backK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
- 4 generations backK070501 Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007
- 3 generations backK113463 Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012
- 2 generations backK220747 Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- 1 generation backK240913 Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd · 2024
- This deviceK251891 Electric Wheelchair (GY-E001)Shandong Guyue Healthcare Appliance Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K023148 | Epw Powered Wheelchair, GP-201 | Emg Technology Co., Ltd. | 2003 | — |
| −5 | K062888 | Middle Wheel Drive Power Chair, CWD01 | Emg Technology Co., Ltd. | 2006 | — |
| −4 | K070501 | Ruike 3421 Powered Wheelchair | Shanghai Ruike Sports Goods Co., Ltd. | 2007 | — |
| −3 | K113463 | Power Wheelchair | Suzhou KD Medical Appliance Co., Ltd. | 2012 | — |
| −2 | K220747 | Power Wheelchair (N5515B) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| −1 | K240913 | Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) | Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd | 2024 | — |
| 0 (this device) | K251891 | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K240913 | Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)Summary page 5….3860 Product Code(s) [Tl I Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K240913 Electric Wheelchair ITl Device Description Summary 21 CFR 807.92(a)(4) and adjusting speed. Products for adult use. Decelera… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K240913.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251891: Electric Wheelchair (GY-E001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251891
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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