510(k) · Cleared
ClearedMobility Scooter, Model: W3331F
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 Oct 17, 2022 as substantially equivalent to K220206 (Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, 2022) after a 60-day review. Its family tree reaches back 8 generations to 1992. 5 later devices descend from it.
- Decided
- Oct 17, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K923193 (1992). 11 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- 7 generations backK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- 6 generations backK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- 5 generations backK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- 4 generations backK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- 3 generations backK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
- 2 generations backK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- 1 generation backK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- This deviceK222495 Mobility Scooter, Model: W3331FZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
- Descendant · cites it directly · 3 of its ownK240008 Mobility Scooter (W3331)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2024
- Descendant · 2 generations on · 1 of its ownK250533 Magnesium alloy scooter (RS100)Taizhou Reach Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK253600 Scooter (YD-03)Yurob Rehabilitation Medical Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252817 Mobility Scooter (BC-MS310)Ningbo Baichen Medical Devices Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242760 WHILL Model RWhill, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K240008Mobility Scooter (W3331)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2024 · cites it directly3descendants
- K250533Magnesium alloy scooter (RS100)Taizhou Reach Technology Co., Ltd. · 2025 · 2 generations on1descendant
- K253600Scooter (YD-03)Yurob Rehabilitation Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K252817Mobility Scooter (BC-MS310)Ningbo Baichen Medical Devices Co., Ltd. · 2026 · 3 generations on0descendants
- K242760WHILL Model RWhill, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| −7 | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| −6 | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −5 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| −4 | K070603 | C.T.M. Mobilitty Scooter # HS-295 | C.T.M. Homecare Product, Inc. | 2007 | — |
| −3 | K162952 | C.T.M. Mobility Scooter | Chien TI Enterprise Co., Ltd. | 2017 | — |
| −2 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| −1 | K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| 0 (this device) | K222495 | Mobility Scooter, Model: W3331F | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
| +1 | K240008 | Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024 | — |
| +2 | K250533 | Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. | 2025 | — |
| +2 | K253600 | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | 2026 | — |
| +3 | K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | 2026 | — |
| +1 | K242760 | WHILL Model R | Whill, Inc. | 2025 | — |
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 | 2 | 0 |
| 2026 | 2 | 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 K231428 Mobility Scooter (Models: W3431D)score 23.1 · 9 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 |
|---|---|---|---|
| * | K220206 | Mobility ScooterSummary page 4…ed three-wheeled vehicle Classification: Class II. Product code: INI Regulation Number: 890.3800 Review Panel: Physical Medicine C. Predicate device: 510Knumber: K220206 Device Name: Mobility Scooter Model: W3468A Zhejiang Innuovo Rehabilitation Devices Co.,Ltd D. Indications for use of the dev… | 2022 |
What descends from it? (5)
2 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 30 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K240008 (Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, 2024) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K220206.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K222495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222495: Mobility Scooter, Model: W3331F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222495
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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