510(k) · Cleared
ClearedJan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jan Mao Industries Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Aug 16, 2006 as substantially equivalent to K051482 (Jan Mao Industries Co., Ltd., 2005) after a 15-day review. Its family tree reaches back 5 generations to 2002. 17 later devices descend from it.
- Decided
- Aug 16, 2006
- Review
- 15 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K020472 (2002). 17 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- 4 generations backK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
- 3 generations backK050290 Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005
- 2 generations backK050708 Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
- 1 generation backK051482 Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005
- This deviceK062218 Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006
- Descendant · cites it directly · 12 of its ownK101999 Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010
- Descendant · 2 generations on · 10 of its ownK112816 Zhenjiang Asure Mechanical WheelchairZhenjiang Assure Medical Equipment Co., Ltd. · 2012
- Descendant · 3 generations on · 7 of its ownK130017 Valentine Steel WheelchairValentine Intl., Ltd. · 2014
- Descendant · 4 generations on · 4 of its ownK153328 SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. · 2016
- Descendant · 5 generations on · 3 of its ownK163352 WheelchairKunshan Hi-Fortune Health Products Co., Ltd. · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K101999Kaiyang Steel WheelchairGuangdong Kaiyang Medical Technology Co., Ltd. · 2010 · cites it directly12descendants
- K112816Zhenjiang Asure Mechanical WheelchairZhenjiang Assure Medical Equipment Co., Ltd. · 2012 · 2 generations on10descendants
- K130017Valentine Steel WheelchairValentine Intl., Ltd. · 2014 · 3 generations on7descendants
- K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. · 2016 · 4 generations on4descendants
- K163352WheelchairKunshan Hi-Fortune Health Products Co., Ltd. · 2017 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K020472 | Biotech Manual Wheelchair B900 Super Light Wheelchair | Taiwan Armada Enterprise Co., Ltd. | 2002 | — |
| −4 | K041337 | Pro Walker ML-300 Foldable Wheelchair | Pro Walker, Inc. | 2004 | — |
| −3 | K050290 | Lerado, Cosco | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| −2 | K050708 | Lerado, Avanticare Mechanical Wheelchair, MR-9000 | Lerado Oversea Ltd. Twn Branch (Bvi) | 2005 | — |
| −1 | K051482 | Jan Mao Wheelchair, Model JMC612-F18EPP | Jan Mao Industries Co., Ltd. | 2005 | — |
| 0 (this device) | K062218 | Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP | Jan Mao Industries Co., Ltd. | 2006 | — |
| +1 | K101999 | Kaiyang Steel Wheelchair | Guangdong Kaiyang Medical Technology Co., Ltd. | 2010 | — |
| +2 | K112816 | Zhenjiang Asure Mechanical Wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | 2012 | — |
| +3 | K130017 | Valentine Steel Wheelchair | Valentine Intl., Ltd. | 2014 | — |
| +4 | K153328 | SUNCO Mechanical Wheelchair, model SKW-9003 | Danyang Sunco Machinery Co., Ltd. | 2016 | — |
| +5 | K163352 | Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K051482 | Jan Mao Wheelchair, Model JMC612-F18EPPSummary page 1…/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. Legally marketed device for substantial equivalence comparison: JAN MAO Wheelchair JMC612-Fl8EPP (K051482) D1… | 2005 |
What descends from it? (17)
See all 173 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 4 companies; a new generation was cleared every 9 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K101999 (Guangdong Kaiyang Medical Technology Co., Ltd., 2010) has gone furthest, with 12 descendants 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.
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/K062218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062218: Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062218
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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