510(k) · Cleared
ClearedHeartway Power Mobility Scooter, S12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartway Medical Products Co., Ltd. · INI Vehicle, Motorized 3-Wheeled
Cleared on Oct 9, 2009 as substantially equivalent to K073044 (Heartway Medical Products Co., Ltd., 2007) after a 43-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 43 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032488 (2003). 3 later devices descend from it, 2 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 backK073044 Heartway Power Mobility Scooter, Model PT7Heartway Medical Products Co., Ltd. · 2007
- This deviceK092650 Heartway Power Mobility Scooter, S12Heartway Medical Products Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK132855 Heartway Power Mobility ScooterHeartway Medical Products Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK234098 Mobility Scooter (C4+)Yongkang Yile Vehicle Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK133187 FREERIDER FR1, models FR1-13, FR1-15, FR1-17Freerider Corp · 2015
Most influential descendants
Showing 3 of 3 · See all- K132855Heartway Power Mobility ScooterHeartway Medical Products Co., Ltd. · 2014 · cites it directly1descendant
- K234098Mobility Scooter (C4+)Yongkang Yile Vehicle Co., Ltd. · 2024 · 2 generations on0descendants
- K133187FREERIDER FR1, models FR1-13, FR1-15, FR1-17Freerider Corp · 2015 · 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 | K073044 | Heartway Power Mobility Scooter, Model PT7 | Heartway Medical Products Co., Ltd. | 2007 | — |
| 0 (this device) | K092650 | Heartway Power Mobility Scooter, S12 | Heartway Medical Products Co., Ltd. | 2009 | — |
| +1 | K132855 | Heartway Power Mobility Scooter | Heartway Medical Products Co., Ltd. | 2014 | — |
| +2 | K234098 | Mobility Scooter (C4+) | Yongkang Yile Vehicle Co., Ltd. | 2024 | — |
| +1 | K133187 | FREERIDER FR1, models FR1-13, FR1-15, FR1-17 | Freerider Corp | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K073044 | Heartway Power Mobility Scooter, Model PT7 | 2007 |
What descends from it? (3)
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 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K132855 (Heartway Medical Products Co., Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K073044.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
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/K092650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092650: Heartway Power Mobility Scooter, S12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092650
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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