510(k) · Cleared
ClearedMobility Scooter (Models: W3431D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · INI Vehicle, Motorized 3-Wheeled
Cleared on Jul 14, 2023 as substantially equivalent to K222507 (Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, 2023) after a 58-day review. Its family tree reaches back 9 generations to 1992. 11 later devices descend from it.
- Decided
- Jul 14, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K923193 (1992). 12 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- 5 generations between
- 3 generations backK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- 2 generations backK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- 1 generation backK222507 Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- This deviceK231428 Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- Descendant · cites it directly · 2 of its ownK252588 Mobility Scooter (T5)Zhejiang Taotao Vehicle Co., Ltd. · 2025
- Descendant · cites it directly · 2 of its ownK252502 Folding Mobility Scooter (KD101)Nanjing Kangni Smart Technology Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK253936 Power Mobility Scooter (MJMA01, MJMA02)Nanjing Mijo Technology Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK240012 Mobility Scooter (W3431)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2024
- Descendant · 2 generations on · 0 of its ownK262553 Mobility Scooter (YQ-401,YQ- 401A,YQ-403,YQ-403A)Zhejiang Kailang Technology Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- 8 generations backK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- 7 generations backK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- 6 generations backK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- 5 generations backK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- 4 generations backK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
- 3 generations backK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- 2 generations backK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- 1 generation backK222507 Mobility Scooter (Models: W3431Q, W3431R)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
- This deviceK231428 Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K252588Mobility Scooter (T5)Zhejiang Taotao Vehicle Co., Ltd. · 2025 · cites it directly2descendants
- K252502Folding Mobility Scooter (KD101)Nanjing Kangni Smart Technology Co., Ltd. · 2025 · cites it directly2descendants
- K253936Power Mobility Scooter (MJMA01, MJMA02)Nanjing Mijo Technology Co., Ltd. · 2026 · cites it directly1descendant
- K240012Mobility Scooter (W3431)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2024 · cites it directly1descendant
- K262553Mobility Scooter (YQ-401,YQ- 401A,YQ-403,YQ-403A)Zhejiang Kailang Technology Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| −8 | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| −7 | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −6 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −5 | K070603 | C.T.M. Mobilitty Scooter # HS-295 | C.T.M. Homecare Product, Inc. | 2007 | — |
| −4 | K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017 | — |
| −3 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| −2 | K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| −1 | K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| 0 (this device) | K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023 | — |
| +1 | K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | 2025 | — |
| +1 | K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | 2025 | — |
| +1 | K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | 2026 | — |
| +1 | K240012 | Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024 | — |
| +2 | K262553 | Mobility Scooter (YQ-401,YQ- 401A,YQ-403,YQ-403A) | Zhejiang Kailang Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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 INI? 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 INI device
- #1 K201196 Scooter (Model: FDB01)score 21.4 · 7 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 |
|---|---|---|---|
| * | K222507 | Mobility Scooter (Models: W3431Q, W3431R)Summary page 4…ized three-wheeled vehicle Classification: Class II. Product code: INI Regulation Number: 890.3800 Review Panel: Physical Medicine C. Predicate device: 510Knumber: K222507 Device Name: Mobility Scooter Model: W3431Q, W3431R Zhejiang Innuovo Rehabilitation Devices Co.,Ltd D. Indic… | 2023 |
What descends from it? (11)
See all 115 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 31 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K252588 (Zhejiang Taotao Vehicle Co., Ltd., 2025) has gone furthest, with 2 descendants of its own.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · INI
21so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · INI
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INI
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INI
26in 2025
MAUDE reports naming product code INI, 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 | 29 | 2 | 64 |
| 2008 | 7 | 28 | 0 | 29 |
| 2009 | 12 | 41 | 0 | 25 |
| 2010 | 5 | 46 | 3 | 56 |
| 2011 | 5 | 130 | 3 | 70 |
| 2012 | 1 | — | 0 | 172 |
| 2013 | 2 | — | 1 | 454 |
| 2014 | 1 | — | 0 | 567 |
| 2015 | 9 | 202 | 0 | 151 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 5 | 191 | 0 | 45 |
| 2018 | 3 | 266 | 0 | 51 |
| 2019 | 4 | 298 | 0 | 25 |
| 2020 | 1 | — | 0 | 26 |
| 2021 | 5 | 575 | 0 | 41 |
| 2022 | 6 | 159 | 0 | 41 |
| 2023 | 9 | 123 | 0 | 32 |
| 2024 | 8 | 137 | 0 | 31 |
| 2025 | 15 | 111 | 0 | 26 |
| 2026 | 21 | 108 | 0 | — |
What is it indicated for?
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231428: Mobility Scooter (Models: W3431D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231428
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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