510(k) · Cleared
ClearedWu's Powered Wheelchair, Mambo 36X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wu'S Tech Co., Ltd. · ITI Wheelchair, Powered
Cleared on Feb 11, 2005 as substantially equivalent to K022697 (Teh Lin Prosthetic & Orthopaedic, Inc., 2003) after a 39-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.
- Decided
- Feb 11, 2005
- Review
- 39 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022697 (2003). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK022697 Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc. · 2003
- This deviceK050010 Wu's Powered Wheelchair, Mambo 36XWu'S Tech Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK070655 Wu's Powered Wheelchair, Mambo 36Wu'S Tech Co., Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK070433 Lerado, Power Wheelchair, PBLerado China Limited · 2007
- Descendant · 2 generations on · 0 of its ownK181163 Wu's Powered WheelchairWu'S Tech Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK130982 Lerado, Power WheelchairLerado Global (Macao Commercial Offshore) Limited · 2014
- Descendant · cites it directly · 0 of its ownK070493 Heartway Power Tilt Seating System Power Chair, P17RTHeartway Medical Products Co., Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K070655Wu's Powered Wheelchair, Mambo 36Wu'S Tech Co., Ltd. · 2007 · cites it directly1descendant
- K070433Lerado, Power Wheelchair, PBLerado China Limited · 2007 · cites it directly1descendant
- K181163Wu's Powered WheelchairWu'S Tech Co., Ltd. · 2019 · 2 generations on0descendants
- K130982Lerado, Power WheelchairLerado Global (Macao Commercial Offshore) Limited · 2014 · 2 generations on0descendants
- K070493Heartway Power Tilt Seating System Power Chair, P17RTHeartway Medical Products Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022697 | Teh Lin Jupiter Power Chair, Model TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003 | — |
| 0 (this device) | K050010 | Wu's Powered Wheelchair, Mambo 36X | Wu'S Tech Co., Ltd. | 2005 | — |
| +1 | K070655 | Wu's Powered Wheelchair, Mambo 36 | Wu'S Tech Co., Ltd. | 2007 | — |
| +1 | K070433 | Lerado, Power Wheelchair, PB | Lerado China Limited | 2007 | — |
| +2 | K181163 | Wu's Powered Wheelchair | Wu'S Tech Co., Ltd. | 2019 | — |
| +2 | K130982 | Lerado, Power Wheelchair | Lerado Global (Macao Commercial Offshore) Limited | 2014 | — |
| +1 | K070493 | Heartway Power Tilt Seating System Power Chair, P17RT | Heartway Medical Products Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2014 | 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 ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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 |
|---|---|---|---|
| * | K022697 | Teh Lin Jupiter Power Chair, Model TL-320Summary page 1…chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: TEH LIN JUPITER Powered Wheelchair TL-320 (K022697) WUS 0,LTD 0 C0… | 2003 |
What descends from it? (5)
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?
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
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/K050010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050010: Wu's Powered Wheelchair, Mambo 36X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050010
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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