510(k) · Cleared
ClearedPower Scooter, Model TL0821
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 Sep 24, 2004 as substantially equivalent to K022698 (Teh Lin Prosthetic & Orthopaedic, Inc., 2002) after a 60-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Sep 24, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- INI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022698 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022698 Scooter Mars Series, Model TL-588Teh Lin Prosthetic & Orthopaedic, Inc. · 2002
- This deviceK042011 Power Scooter, Model TL0821Teh Lin Prosthetic & Orthopaedic, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK051118 Model TL-360 Power ScooterTeh Lin Prosthetic & Orthopaedic, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK051116 Model TL-560 Power ScooterTeh Lin Prosthetic & Orthopaedic, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022698 | Scooter Mars Series, Model TL-588 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2002 | — |
| 0 (this device) | K042011 | Power Scooter, Model TL0821 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004 | — |
| +1 | K051118 | Model TL-360 Power Scooter | Teh Lin Prosthetic & Orthopaedic, Inc. | 2005 | — |
| +1 | K051116 | Model TL-560 Power Scooter | Teh Lin Prosthetic & Orthopaedic, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 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 |
|---|---|---|---|
| * | K022698 | Scooter Mars Series, Model TL-588Summary page 1…chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: TEH LIN POWER SCOOTER TL-S88(K0226 98) TEH LIN PROSTHETIC & ORTHOPAEDIC INC. No. 7, Wu Chuan 7 t h Road, WuKu Industrial Par… | 2002 |
What descends from it? (2)
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?
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 sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042011 · printed Nov 3, 2026
Cite this page
510(k) Report. “K042011: Power Scooter, Model TL0821.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K042011
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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