510(k) · Cleared
ClearedBiotech Manual Wheelchair B900 Super Light Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Armada Enterprise Co., Ltd. · IOR Wheelchair, Mechanical
Cleared on Mar 8, 2002 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 32 later devices descend from it.
- Decided
- Mar 8, 2002
- Review
- 24 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 2 citing it directly.
- This deviceK020472 Biotech Manual Wheelchair B900 Super Light WheelchairTaiwan Armada Enterprise Co., Ltd. · 2002
- Descendant · cites it directly · 30 of its ownK041337 Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004
- Descendant · 2 generations on · 22 of its ownK050290 Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005
- Descendant · 3 generations on · 20 of its ownK050708 Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005
- Descendant · 4 generations on · 18 of its ownK051482 Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005
- Descendant · 5 generations on · 17 of its ownK062218 Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K041337Pro Walker ML-300 Foldable WheelchairPro Walker, Inc. · 2004 · cites it directly30descendants
- K050290Lerado, CoscoLerado Oversea Ltd. Twn Branch (Bvi) · 2005 · 2 generations on22descendants
- K050708Lerado, Avanticare Mechanical Wheelchair, MR-9000Lerado Oversea Ltd. Twn Branch (Bvi) · 2005 · 3 generations on20descendants
- K051482Jan Mao Wheelchair, Model JMC612-F18EPPJan Mao Industries Co., Ltd. · 2005 · 4 generations on18descendants
- K062218Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPJan Mao Industries Co., Ltd. · 2006 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | 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 | — |
| +4 | K051482 | Jan Mao Wheelchair, Model JMC612-F18EPP | Jan Mao Industries Co., Ltd. | 2005 | — |
| +5 | K062218 | Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPP | Jan Mao Industries Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (32)
See all 322 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?
- Of its descendants, K041337 (Pro Walker, Inc., 2004) has gone furthest, with 30 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 person restricted to a sitting position.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020472: Biotech Manual Wheelchair B900 Super Light Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020472
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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