510(k) · Cleared
ClearedC.T.M. Mobility Scooter, Model HS-120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.T.M. Homecare Product, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on May 20, 2003 as substantially equivalent to K012791 (Warepalmy Enterprise, LLC (Usa), 2001) after a 28-day review. Its family tree reaches back 2 generations to 1992. 40 later devices descend from it.
- Decided
- May 20, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923193 (1992). 40 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923193 Sunrunner TE-777Pride Health Care, Inc. · 1992
- 1 generation backK012791 C.T.M. Mobility Scooter Model # HS-320Warepalmy Enterprise, LLC (Usa) · 2001
- This deviceK031272 C.T.M. Mobility Scooter, Model HS-120C.T.M. Homecare Product, Inc. · 2003
- Descendant · cites it directly · 37 of its ownK032919 C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003
- Descendant · 2 generations on · 36 of its ownK070603 C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007
- Descendant · 3 generations on · 35 of its ownK162952 C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017
- Descendant · 4 generations on · 34 of its ownK182471 ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019
- Descendant · 5 generations on · 19 of its ownK220206 Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K032919C.T.M. Mobility Scooter, Model HS-250C.T.M. Homecare Product, Inc. · 2003 · cites it directly37descendants
- K070603C.T.M. Mobilitty Scooter # HS-295C.T.M. Homecare Product, Inc. · 2007 · 2 generations on36descendants
- K162952C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. · 2017 · 3 generations on35descendants
- K182471ScooterTianjin Kepler Vehicle Industry Co., Ltd. · 2019 · 4 generations on34descendants
- K220206Mobility ScooterZhejiang Innuovo Rehabilitation Devices Co.,Ltd · 2022 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923193 | Sunrunner TE-777 | Pride Health Care, Inc. | 1992 | — |
| −1 | K012791 | C.T.M. Mobility Scooter Model # HS-320 | Warepalmy Enterprise, LLC (Usa) | 2001 | — |
| 0 (this device) | K031272 | C.T.M. Mobility Scooter, Model HS-120 | C.T.M. Homecare Product, Inc. | 2003 | — |
| +1 | K032919 | C.T.M. Mobility Scooter, Model HS-250 | C.T.M. Homecare Product, Inc. | 2003 | — |
| +2 | 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 | — |
| +4 | K182471 | Scooter | Tianjin Kepler Vehicle Industry Co., Ltd. | 2019 | — |
| +5 | K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K012791 | C.T.M. Mobility Scooter Model # HS-320Summary page 1…e for substantial equivalence comparison: C.T.M. Mobility Scooter HS-320 submitted by Warepalmy Enterprise LLC (USA) and cleared for marketing under 510(k) k012791. Description of the device: The C.T.M. Mobility Scooter HS-120 is an indoor/outdoor electric scooter that is batte… | 2001 |
What descends from it? (40)
See all 402 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 11 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032919 (C.T.M. Homecare Product, Inc., 2003) has gone furthest, with 37 descendants of its own.
- 1 other device also cites its predicate K012791.
How does its category compare?
All INI devicesINI Vehicle, Motorized 3-Wheeled: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 C.T.M. Mobility Scooter HS-120 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031272 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031272: C.T.M. Mobility Scooter, Model HS-120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031272
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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