510(k) · Cleared
ClearedA08 Power wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kunshan Aoshida Electric Technology Co., Ltd. · ITI Wheelchair, Powered
Cleared on May 5, 2017 as substantially equivalent to K113463 (Suzhou KD Medical Appliance Co., Ltd., 2012) after a 171-day review. Its family tree reaches back 4 generations to 2003. 7 later devices descend from it.
- Decided
- May 5, 2017
- Review
- 171 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K023148 (2003). 7 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
- 3 generations backK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
- 2 generations backK070501 Ruike 3421 Powered WheelchairShanghai Ruike Sports Goods Co., Ltd. · 2007
- 1 generation backK113463 Power WheelchairSuzhou KD Medical Appliance Co., Ltd. · 2012
- This deviceK163204 A08 Power wheelchairKunshan Aoshida Electric Technology Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK241529 Powered Wheelchair (NXN20-209)Zhejiang Nysin Medical Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK232783 Power wheelchair (Model: JMPW-01W)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252862 Electric Wheelchair (DH01126)Foshan Dahao Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK241588 Electric Wheelchair (KR8803)Zhejiang Kairui Medical Device Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK241603 Powered Wheelchair (NXN20-208, NXN20-211)Zhejiang Nysin Medical Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K241529Powered Wheelchair (NXN20-209)Zhejiang Nysin Medical Co., Ltd. · 2024 · cites it directly1descendant
- K232783Power wheelchair (Model: JMPW-01W)Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · 2024 · cites it directly1descendant
- K252862Electric Wheelchair (DH01126)Foshan Dahao Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K241588Electric Wheelchair (KR8803)Zhejiang Kairui Medical Device Co., Ltd. · 2024 · 2 generations on0descendants
- K241603Powered Wheelchair (NXN20-208, NXN20-211)Zhejiang Nysin Medical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K023148 | Epw Powered Wheelchair, GP-201 | Emg Technology Co., Ltd. | 2003 | — |
| −3 | 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 | — |
| −1 | K113463 | Power Wheelchair | Suzhou KD Medical Appliance Co., Ltd. | 2012 | — |
| 0 (this device) | K163204 | A08 Power wheelchair | Kunshan Aoshida Electric Technology Co., Ltd. | 2017 | — |
| +1 | K241529 | Powered Wheelchair (NXN20-209) | Zhejiang Nysin Medical Co., Ltd. | 2024 | — |
| +1 | K232783 | Power wheelchair (Model: JMPW-01W) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2024 | — |
| +2 | K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. | 2025 | — |
| +2 | K241588 | Electric Wheelchair (KR8803) | Zhejiang Kairui Medical Device Co., Ltd. | 2024 | — |
| +1 | K241603 | Powered Wheelchair (NXN20-208, NXN20-211) | Zhejiang Nysin Medical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K113463 | Power WheelchairSummary page 4…ce Regulation number: 890.3860 Product code: ITI Classification: Class II Predicate devices Trade name: PL001 power wheelchair 510(k) number: K113463 Manufacture: SUZHOU KD MEDICAL APPLIANCE CO. LTD. Regulation number: 890.3860 Product Code: ITI Classificatio… | 2012 |
What descends from it? (7)
5 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 14 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K241529 (Zhejiang Nysin Medical Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K113463.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 device 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/K163204 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163204: A08 Power wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163204
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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