510(k) · Cleared
ClearedTeh Lin Jupiter Power Chair, Model TL-320
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teh Lin Prosthetic & Orthopaedic, Inc. · ITI Wheelchair, Powered
Cleared on Jan 24, 2003 after a 164-day review. The FDA summary names no predicate by number. 21 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 164 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 4 citing it directly.
- This deviceK022697 Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc. · 2003
- Descendant · cites it directly · 12 of its ownK061693 Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd. · 2006
- Descendant · 2 generations on · 9 of its ownK070489 Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007
- Descendant · 3 generations on · 5 of its ownK071006 Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007
- Descendant · cites it directly · 5 of its ownK050010 Wu's Powered Wheelchair, Mambo 36XWu'S Tech Co., Ltd. · 2005
- Descendant · 4 generations on · 1 of its ownK111095 Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K061693Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd. · 2006 · cites it directly12descendants
- K070489Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007 · 2 generations on9descendants
- K071006Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007 · 3 generations on5descendants
- K050010Wu's Powered Wheelchair, Mambo 36XWu'S Tech Co., Ltd. · 2005 · cites it directly5descendants
- K111095Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022697 | Teh Lin Jupiter Power Chair, Model TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003 | — |
| +1 | K061693 | Foryou Powered Wheelchair, Model FC-100 | Foryou Technology Co., Ltd. | 2006 | — |
| +2 | K070489 | Heartway Power Tilt Seating System Power Chair, Model# P16RT | Heartway Medical Products Co., Ltd. | 2007 | — |
| +3 | K071006 | Heartway Attendant-Controlled Power Chair, TC1 | Heartway Medical Products Co., Ltd. | 2007 | — |
| +1 | K050010 | Wu's Powered Wheelchair, Mambo 36X | Wu'S Tech Co., Ltd. | 2005 | — |
| +4 | K111095 | Breeze Electric Transport Chair Model 1025 | Electro Kinetic Technologies, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2019 | 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 ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (21)
See all 214 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, K061693 (Foryou Technology Co., Ltd., 2006) has gone furthest, with 12 descendants of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The device is intended for medical purposes to provide mobility to Demons restricted to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022697: Teh Lin Jupiter Power Chair, Model TL-320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022697
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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