510(k) · Cleared
ClearedWH Convertible Lightweght Wheelchair, Model WHL100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Home Health Products Co. · IOR Wheelchair, Mechanical
Cleared on Mar 8, 2006 as substantially equivalent to K041337 (Pro Walker, Inc., 2004) after a 36-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- Mar 8, 2006
- Review
- 36 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020472 (2002). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- 1 generation backK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
- This deviceK060251 WH Convertible Lightweght Wheelchair, Model WHL100Well Home Health Products Co. · 2006
- Descendant · cites it directly · 3 of its ownK062311 Karma Manual Wheelchair, Model Budget 800Karma Medical Products Co., Ltd. · 2006
- Descendant · 2 generations on · 2 of its ownK132257 Manual WheelchairZhejiang Jiafeng Electrical & Mechanial Co., Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK151797 Nuocande Plastic Manual Wheelchair Model NKD L07Ningbo Lecount Medical Technology Co., Ltd. · 2015
- Descendant · 4 generations on · 0 of its ownK180309 Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK062309 Karma Manual Wheelchair, Models S-Ergo 305 and S-Ergo 105Karma Medical Products Co., Ltd. · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062311Karma Manual Wheelchair, Model Budget 800Karma Medical Products Co., Ltd. · 2006 · cites it directly3descendants
- K132257Manual WheelchairZhejiang Jiafeng Electrical & Mechanial Co., Ltd. · 2014 · 2 generations on2descendants
- K151797Nuocande Plastic Manual Wheelchair Model NKD L07Ningbo Lecount Medical Technology Co., Ltd. · 2015 · 3 generations on1descendant
- K180309Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd. · 2019 · 4 generations on0descendants
- K062309Karma Manual Wheelchair, Models S-Ergo 305 and S-Ergo 105Karma Medical Products Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020472 | Biotech Manual Wheelchair B900 Super Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | 2002 | — |
| −1 | K041337 | Pro Walker ML-300 Foldable Wheelchair | Pro Walker, Inc. | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K132257 | Manual Wheelchair | Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. | 2014 | — |
| +3 | K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07 | Ningbo Lecount Medical Technology Co., Ltd. | 2015 | — |
| +4 | K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019 | — |
| +1 | K062309 | Karma Manual Wheelchair, Models S-Ergo 305 and S-Ergo 105 | Karma Medical Products Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K041337 | Pro Walker ML-300 Foldable WheelchairSummary page 1…NSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. Legally marketed device for substantial equivalence comparison: PRO WALKER ML-300 Foldable Wheelchair ( K041337 ). fe 3W Horne Health Products Co 2 A ifn ! a' , Yo l ;-'l… | 2004 |
What descends from it? (6)
3 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 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062311 (Karma Medical Products Co., Ltd., 2006) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K041337.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060251 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060251: WH Convertible Lightweght Wheelchair, Model WHL100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060251
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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