510(k) · Cleared
ClearedScooter Mars Series, Model TL-588
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teh Lin Prosthetic & Orthopaedic, Inc. · INI Vehicle, Motorized 3-Wheeled
Cleared on Dec 2, 2002 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 2, 2002
- Review
- 111 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK022698 Scooter Mars Series, Model TL-588Teh Lin Prosthetic & Orthopaedic, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK042011 Power Scooter, Model TL0821Teh Lin Prosthetic & Orthopaedic, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK051118 Model TL-360 Power ScooterTeh Lin Prosthetic & Orthopaedic, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK051116 Model TL-560 Power ScooterTeh Lin Prosthetic & Orthopaedic, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK042012 Teh Lin Power Scooter, Model TL-822Teh Lin Prosthetic & Orthopaedic, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK042010 Power Scooter, Model TL-688Teh Lin Prosthetic & Orthopaedic, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K042011Power Scooter, Model TL0821Teh Lin Prosthetic & Orthopaedic, Inc. · 2004 · cites it directly2descendants
- K051118Model TL-360 Power ScooterTeh Lin Prosthetic & Orthopaedic, Inc. · 2005 · 2 generations on0descendants
- K051116Model TL-560 Power ScooterTeh Lin Prosthetic & Orthopaedic, Inc. · 2005 · 2 generations on0descendants
- K042012Teh Lin Power Scooter, Model TL-822Teh Lin Prosthetic & Orthopaedic, Inc. · 2004 · cites it directly0descendants
- K042010Power Scooter, Model TL-688Teh Lin Prosthetic & Orthopaedic, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022698 | Scooter Mars Series, Model TL-588 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2002 | — |
| +1 | K042011 | Power Scooter, Model TL0821 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004 | — |
| +2 | K051118 | Model TL-360 Power Scooter | Teh Lin Prosthetic & Orthopaedic, Inc. | 2005 | — |
| +2 | K051116 | Model TL-560 Power Scooter | Teh Lin Prosthetic & Orthopaedic, Inc. | 2005 | — |
| +1 | K042012 | Teh Lin Power Scooter, Model TL-822 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004 | — |
| +1 | K042010 | Power Scooter, Model TL-688 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 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?
- Of its descendants, K042011 (Teh Lin Prosthetic & Orthopaedic, Inc., 2004) has gone furthest, with 2 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.
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 510(k) statement.
https://510kreport.com/device/K022698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022698: Scooter Mars Series, Model TL-588.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022698
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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