510(k) · Cleared
ClearedKaiyang Aluminum Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Kaiyang Medical Technology Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Oct 4, 2010 as substantially equivalent to K062218 (Jan Mao Industries Co., Ltd., 2006) after an 81-day review. Its family tree reaches back 6 generations to 2002. 2 later devices descend from it.
- Decided
- Oct 4, 2010
- Review
- 81 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K020472 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- 5 generations backK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
- 4 generations backK050290 Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005
- 3 generations backK050708 Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
- 2 generations backK051482 Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005
- 1 generation backK062218 Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006
- This deviceK101998 Kaiyang Aluminum WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK130848 Shanghai Phoenix Mechanical WheelchairShanghai Phoenix Medical Equipment Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK112948 Jiangsu Healthy Way Mechanical WheelchairJiangsu Healthy Way Medical Equipment Co;Ltd · 2012
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 | K020472 | Biotech Manual Wheelchair B900 Super Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | 2002 | — |
| −5 | K041337 | Pro Walker ML-300 Foldable Wheelchair | Pro Walker, Inc. | 2004 | — |
| −4 | K050290 | Lerado, Cosco | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| −3 | K050708 | Lerado, Avanticare Mechanical Wheelchair, MR-9000 | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| −2 | K051482 | Jan Mao Wheelchair, Model JMC612-F18EPP | Jan Mao Industries Co., Ltd. | 2005 | — |
| −1 | K062218 | Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP | Jan Mao Industries Co., Ltd. | 2006 | — |
| 0 (this device) | K101998 | Kaiyang Aluminum Wheelchair | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010 | — |
| +1 | K130848 | Shanghai Phoenix Mechanical Wheelchair | Shanghai Phoenix Medical Equipment Co., Ltd. | 2013 | — |
| +1 | K112948 | Jiangsu Healthy Way Mechanical Wheelchair | Jiangsu Healthy Way Medical Equipment Co;Ltd | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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 IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 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 |
|---|---|---|---|
| * | K062218 | Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPSummary page 1…SO 7176 Wheelchair Standards. Legally marketed device for substantial equivalence comparison: JAN MAO Wheelchair JMC612-FL318 EPP & JMC612-FL418EZPP (K062218) Guangdoug Kaiyang Medical Technology Co., Ltd. Yanfeng Industrial Area, Dali, N… | 2006 |
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 8 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K130848 (Shanghai Phoenix Medical Equipment Co., Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062218.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101998 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101998: Kaiyang Aluminum Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101998
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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