510(k) · Cleared
ClearedManual Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Feb 13, 2014 as substantially equivalent to K062311 (Karma Medical Products Co., Ltd., 2006) after a 209-day review. Its family tree reaches back 4 generations to 2002. 2 later devices descend from it.
- Decided
- Feb 13, 2014
- Review
- 209 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020472 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- 3 generations backK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
- 2 generations backK060251 WH Convertible Lightweght Wheelchair, Model WHL100Well Home Health Products Co. · 2006
- 1 generation backK062311 Karma Manual Wheelchair, Model Budget 800Karma Medical Products Co., Ltd. · 2006
- This deviceK132257 Manual WheelchairZhejiang Jiafeng Electrical & Mechanial Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK151797 Nuocande Plastic Manual Wheelchair Model NKD L07Ningbo Lecount Medical Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK180309 Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019
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 |
|---|---|---|---|---|---|
| −4 | K020472 | Biotech Manual Wheelchair B900 Super Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | 2002 | — |
| −3 | K041337 | Pro Walker ML-300 Foldable Wheelchair | Pro Walker, Inc. | 2004 | — |
| −2 | K060251 | WH Convertible Lightweght Wheelchair, Model WHL100 | Well Home Health Products Co. | 2006 | — |
| −1 | K062311 | Karma Manual Wheelchair, Model Budget 800 | Karma Medical Products Co., Ltd. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K062311 | Karma Manual Wheelchair, Model Budget 800Summary page 1…I Regulation Number: 21 CFR 890.3850 Panel: General Physical Medicine Product Code: IOR Predicate Device Information: (1) K06231 1, "KARMA Manual Wheelchair, Budget 800", manufactured by "KARMA Medical Products Co., Ltd." Device description: A mechanical whe… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07 | 2015 | 1 |
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 12 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151797 (Ningbo Lecount Medical Technology Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 packed dirt) that are free of large obstacles and inclines greater than 8 degrees.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132257: Manual Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132257
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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