510(k) · Cleared
ClearedSupaScoota Motorized vehicle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eurogreen International, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on Sep 16, 2015 as substantially equivalent to K101143 (Heartway Medical Products Co., Ltd., 2010) and 1 other predicate after a 275-day review. Its family tree reaches back 4 generations to 2003. 1 later device descends from it.
- Decided
- Sep 16, 2015
- Review
- 275 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K032488 (2003). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK032488 Wu's 3-Wheeled Neo Scooter, WT-T3DWu'S Tech Co., Ltd. · 2003
- 3 generations backK071007 Heartway Lightweight Power Mobility Scooter, S33Heartway Medical Products Co., Ltd. · 2007
- 2 generations backK072104 Heartway Power Mobility Scooter, PF6Heartway Medical Products Co., Ltd. · 2007
- 1 generation backK101143 Heartway Power Mobility Scooter, S11Heartway Medical Products Co., Ltd. · 2010
- This deviceK143557 SupaScoota Motorized vehicleEurogreen International, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK182631 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)Eurogreen International, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182631SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)Eurogreen International, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032488 | Wu's 3-Wheeled Neo Scooter, WT-T3D | Wu'S Tech Co., Ltd. | 2003 | — |
| −3 | K071007 | Heartway Lightweight Power Mobility Scooter, S33 | Heartway Medical Products Co., Ltd. | 2007 | — |
| −2 | K072104 | Heartway Power Mobility Scooter, PF6 | Heartway Medical Products Co., Ltd. | 2007 | — |
| −1 | K101143 | Heartway Power Mobility Scooter, S11 | Heartway Medical Products Co., Ltd. | 2010 | — |
| 0 (this device) | K143557 | SupaScoota Motorized vehicle | Eurogreen International, Inc. | 2015 | — |
| +1 | K182631 | SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) | Eurogreen International, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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 |
|---|---|---|---|
| * | K101143 | Heartway Power Mobility Scooter, S11Summary page 9…s are very similar, varying only in minor parameters such as the grade climbable by the respective scooters. EUROGREEN International Inc. HEARTWAY USA. FREERIDER Corp. K101143 K110165 K number - Appendix 9.1 Appendix 9.2 Indication for Use As a motorized portable electric vehicle for indoor or outside… | 2010 |
| * | K110165 | Freerider Model Luggie Model 168-4ITSummary page 9…ry similar, varying only in minor parameters such as the grade climbable by the respective scooters. EUROGREEN International Inc. HEARTWAY USA. FREERIDER Corp. K101143 K110165 K number - Appendix 9.1 Appendix 9.2 Indication for Use As a motorized portable electric vehicle for indoor or outside use by p… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182631 | SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) | 2019 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K182631 (Eurogreen International, Inc., 2019) has gone furthest, with 0 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. 2015, 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?
As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143557: SupaScoota Motorized vehicle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143557
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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