510(k) · Cleared
ClearedManual Wheelchair W54
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Jumao Medical Equipment Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on May 3, 2019 as substantially equivalent to K170517 (Merits Healthcare Industries (Suzhou) Co., Ltd., 2017) and 1 other predicate after a 455-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- May 3, 2019
- Review
- 455 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K020472 (2002). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 backK060251 WH Convertible Lightweght Wheelchair, Model WHL100Well Home Health Products Co. · 2006
- 3 generations backK062311 Karma Manual Wheelchair, Model Budget 800Karma Medical Products Co., Ltd. · 2006
- 2 generations backK132257 Manual WheelchairZhejiang Jiafeng Electrical & Mechanial Co., Ltd. · 2014
- 1 generation backK151797 Nuocande Plastic Manual Wheelchair Model NKD L07Ningbo Lecount Medical Technology Co., Ltd. · 2015
- This deviceK180309 Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019
View 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 | K060251 | WH Convertible Lightweght Wheelchair, Model WHL100 | Well Home Health Products Co. | 2006 | — |
| −3 | K062311 | Karma Manual Wheelchair, Model Budget 800 | Karma Medical Products Co., Ltd. | 2006 | — |
| −2 | K132257 | Manual Wheelchair | Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. | 2014 | — |
| −1 | K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07 | Ningbo Lecount Medical Technology Co., Ltd. | 2015 | — |
| 0 (this device) | K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K170517 | Merits Model R106/R136 Rehab WheelchairSummary page 4…: Manual Wheelchair W54 Model: W54 Classification Panel: Physical Medicine Product Code: IOR Device Classification: Class I 4. The Predicate Devices Primary Predicate: K170517 Merits Model R106/R136 Rehab Wheelchair Secondary Predicate: K151797 Nuocande Plastic Manual Wheelchair Model NKD L07 5. Device… | 2017 |
| * | K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07Summary page 4…icine Product Code: IOR Device Classification: Class I 4. The Predicate Devices Primary Predicate: K170517 Merits Model R106/R136 Rehab Wheelchair Secondary Predicate: K151797 Nuocande Plastic Manual Wheelchair Model NKD L07 5. Device Description A mechanical wheelchair is a chair with wheels, designed… | 2015 |
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 17 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K170517.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.
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/K180309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180309: Manual Wheelchair W54.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180309
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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