510(k) · Cleared
ClearedElectrically powered wheelchair (KZ301B)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanjing Kangni Smart Technology Co., Ltd. · ITI Wheelchair, Powered
Cleared on Dec 5, 2025 as substantially equivalent to K231508 (Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, 2023) after a 119-day review. Its family tree reaches back 6 generations to 2003. 2 later devices descend from it.
- Decided
- Dec 5, 2025
- Review
- 119 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K023148 (2003). 2 later devices descend from it, 2 citing it directly.
- 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 backK231508 Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- This deviceK252494 Electrically powered wheelchair (KZ301B)Nanjing Kangni Smart Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK261354 Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261164 Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd. · 2026
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 |
|---|---|---|---|---|---|
| −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 | K231508 | Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| 0 (this device) | K252494 | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. | 2025 | — |
| +1 | K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | 2026 | — |
| +1 | K261164 | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K231508 | Power Wheelchair, W5521Summary page 5…elchair Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI III. Predicate device K231508 Power wheelchair, W5521 Zhejiang Innuovo Rehabilitation Devices Co., Ltd. IV. Device Description The Electrically powered w… | 2023 |
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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K261354 (Foshan Sowell Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K231508.
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?
The Electrically powered wheelchair 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 as stated in the FDA summary.
https://510kreport.com/device/K252494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252494: Electrically powered wheelchair (KZ301B).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252494
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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