510(k) · Cleared
ClearedBreeze Electric Transport Chair Model 1025
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Kinetic Technologies, LLC · ITI Wheelchair, Powered
Cleared on Aug 3, 2011 as substantially equivalent to K071006 (Heartway Medical Products Co., Ltd., 2007) after a 105-day review. Its family tree reaches back 4 generations to 2003. 1 later device descends from it.
- Decided
- Aug 3, 2011
- Review
- 105 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022697 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK022697 Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc. · 2003
- 3 generations backK061693 Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd. · 2006
- 2 generations backK070489 Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007
- 1 generation backK071006 Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007
- This deviceK111095 Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011
- Descendant · cites it directly · 0 of its ownK130517 EZ Transport ChairHarris Medical, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K130517EZ Transport ChairHarris Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022697 | Teh Lin Jupiter Power Chair, Model TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003 | — |
| −3 | 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 | — |
| −1 | K071006 | Heartway Attendant-Controlled Power Chair, TC1 | Heartway Medical Products Co., Ltd. | 2007 | — |
| 0 (this device) | K111095 | Breeze Electric Transport Chair Model 1025 | Electro Kinetic Technologies, LLC | 2011 | — |
| +1 | K130517 | EZ Transport Chair | Harris Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K071006 | Heartway Attendant-Controlled Power Chair, TC1Summary page 1…ification: Wheelchair, Powered Wheelchair - 21 CFR 890.3860 Class: Class 11 Product Code: ITT Predicate Device: 1-eartway Attendant-Controlled Power Chair, TCl1 (K071006) Intended Use The BREEZ Electric Transport Chair is intended to transport patients within acute, alternative and long term care… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130517 | EZ Transport Chair | 2014 | 0 |
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 8 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130517 (Harris Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071006.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 BREEZ Electric Transport Chair is intended to transport patients within acute,
alternative and long term care facilities. The device can be operated indoors on
carpeting, linoleum and other floors, and on sidewalks. The BREEZ Electric
Transport Chair is controlled, steered and operated completely by a trained caregiver.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111095: Breeze Electric Transport Chair Model 1025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111095
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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