510(k) · Cleared
ClearedHeartway Lightweight Power Mobility Scooter, S34
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 May 26, 2010 as substantially equivalent to K071007 (Heartway Medical Products Co., Ltd., 2007) after a 34-day review. Its family tree reaches back 2 generations to 2003. 12 later devices descend from it.
- Decided
- May 26, 2010
- Review
- 34 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032488 (2003). 12 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK032488 Wu's 3-Wheeled Neo Scooter, WT-T3DWu'S Tech Co., Ltd. · 2003
- 1 generation backK071007 Heartway Lightweight Power Mobility Scooter, S33Heartway Medical Products Co., Ltd. · 2007
- This deviceK101142 Heartway Lightweight Power Mobility Scooter, S34Heartway Medical Products Co., Ltd. · 2010
- Descendant · cites it directly · 9 of its ownK150987 HEARTWAY Power Mobility Scooter, BRIO S19Heartway Medical Products Co., Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK220227 Auto Folding Scooter, S21FHeartway Medical Products Co., Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK232692 Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)Intradin (Shanghai) Machinery Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK191356 i3 Foldable Mobility ScooterPuc Perfect Union Co., Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK252349 Electric Scooter (Mojo-T330)Dongguan Smarfody Mobility Technology Co., Ltd. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K150987HEARTWAY Power Mobility Scooter, BRIO S19Heartway Medical Products Co., Ltd. · 2015 · cites it directly9descendants
- K220227Auto Folding Scooter, S21FHeartway Medical Products Co., Ltd. · 2022 · 2 generations on5descendants
- K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)Intradin (Shanghai) Machinery Co., Ltd. · 2024 · 3 generations on3descendants
- K191356i3 Foldable Mobility ScooterPuc Perfect Union Co., Ltd. · 2022 · 2 generations on2descendants
- K252349Electric Scooter (Mojo-T330)Dongguan Smarfody Mobility Technology Co., Ltd. · 2026 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032488 | Wu's 3-Wheeled Neo Scooter, WT-T3D | Wu'S Tech Co., Ltd. | 2003 | — |
| −1 | K071007 | Heartway Lightweight Power Mobility Scooter, S33 | Heartway Medical Products Co., Ltd. | 2007 | — |
| 0 (this device) | K101142 | Heartway Lightweight Power Mobility Scooter, S34 | Heartway Medical Products Co., Ltd. | 2010 | — |
| +1 | K150987 | HEARTWAY Power Mobility Scooter, BRIO S19 | Heartway Medical Products Co., Ltd. | 2015 | — |
| +2 | K220227 | Auto Folding Scooter, S21F | Heartway Medical Products Co., Ltd. | 2022 | — |
| +3 | K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) | Intradin (Shanghai) Machinery Co., Ltd. | 2024 | — |
| +2 | K191356 | i3 Foldable Mobility Scooter | Puc Perfect Union Co., Ltd. | 2022 | — |
| +4 | K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K071007 | Heartway Lightweight Power Mobility Scooter, S33Summary page 1…chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: HEARTWAY Lightweight Power Mobility Scooter, S33 (K071007) DI === Page 2 =… | 2007 |
What descends from it? (12)
See all 123 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 7 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150987 (Heartway Medical Products Co., Ltd., 2015) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K071007.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101142: Heartway Lightweight Power Mobility Scooter, S34.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101142
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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