510(k) · Cleared
ClearedRuike 3421 Powered Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Ruike Sports Goods Co., Ltd. · ITI Wheelchair, Powered
Cleared on Mar 22, 2007 as substantially equivalent to K062888 (Emg Technology Co., Ltd., 2006) after a 29-day review. Its family tree reaches back 2 generations to 2003. 73 later devices descend from it.
- Decided
- Mar 22, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023148 (2003). 73 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
- 1 generation backK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
- This deviceK070501 Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007
- Descendant · cites it directly · 71 of its ownK113463 Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012
- Descendant · 2 generations on · 37 of its ownK220747 Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- Descendant · 3 generations on · 8 of its ownK231508 Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · 3 generations on · 7 of its ownK230964 Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · 2 generations on · 7 of its ownK163204 A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd. · 2017
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K113463Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012 · cites it directly71descendants
- K220747Power Wheelchair (N5515B)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 2 generations on37descendants
- K231508Power Wheelchair, W5521Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 3 generations on8descendants
- K230964Power Wheelchair (N5909)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023 · 3 generations on7descendants
- K163204A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd. · 2017 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023148 | Epw Powered Wheelchair, GP-201 | Emg Technology Co., Ltd. | 2003 | — |
| −1 | K062888 | Middle Wheel Drive Power Chair, CWD01 | Emg Technology Co., Ltd. | 2006 | — |
| 0 (this device) | K070501 | Ruike 3421 Powered Wheelchair | Shanghai Ruike Sports Goods Co., Ltd. | 2007 | — |
| +1 | K113463 | Power Wheelchair | Suzhou KD Medical Appliance Co., Ltd. | 2012 | — |
| +2 | K220747 | Power Wheelchair (N5515B) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| +3 | K231508 | Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +3 | K230964 | Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +2 | K163204 | A08 Power wheelchair | Kunshan Aoshida Electric Technology Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K062888 | Middle Wheel Drive Power Chair, CWD01Summary page 1…cal specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class H Predicate devices CWD01 (K062888) / EMG Technology Co. Ltd. Intend use of device Ruike 3421 powered wheelchair is intended for an indoor/outdoor power… | 2006 |
What descends from it? (73)
See all 732 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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113463 (Suzhou KD Medical Appliance Co., Ltd., 2012) has gone furthest, with 71 descendants of its own.
- 4 other devices also cite its predicate K062888.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070501: Ruike 3421 Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070501
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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