510(k) · Cleared
ClearedEZ Transport Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harris Medical, LLC · IOR Wheelchair, Mechanical
Cleared on Feb 25, 2014 as substantially equivalent to K935398 (Invacare Corp., 1994) and 2 other predicates after a 363-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Feb 25, 2014
- Review
- 363 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K022697 (2003). 10 ancestors in all, the oldest K885343 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK022697 Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc. · 2003
- 4 generations backK061693 Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd. · 2006
- 3 generations backK070489 Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007
- 2 generations backK071006 Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007
- 1 generation backK111095 Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011
- This deviceK130517 EZ Transport ChairHarris Medical, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K022697 | Teh Lin Jupiter Power Chair, Model TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003 | — |
| −4 | K061693 | Foryou Powered Wheelchair, Model FC-100 | Foryou Technology Co., Ltd. | 2006 | — |
| −3 | K070489 | Heartway Power Tilt Seating System Power Chair, Model# P16RT | Heartway Medical Products Co., Ltd. | 2007 | — |
| −2 | K071006 | Heartway Attendant-Controlled Power Chair, TC1 | Heartway Medical Products Co., Ltd. | 2007 | — |
| −1 | K111095 | Breeze Electric Transport Chair Model 1025 | Electro Kinetic Technologies, LLC | 2011 | — |
| 0 (this device) | K130517 | EZ Transport Chair | Harris Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 IOR? 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 IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K935398 | Tracer Series Manual WheelchairsSummary page 3…t to Invacare Corporation manual wheelchairs (ALBI9HBFR). The above device was granted marketing clearance by the FDA on March 1" 1994, under 510OK number K 935398 and Electro kinetic Technologies KI 11095 and Barton Medical, K07 1793. 8. PERFORMANCE STANDARDS No performance sta… | 1994 |
| * | K111095 | Breeze Electric Transport Chair Model 1025Summary page 1…I Product Code: IOR 3. PREDICAlT DEvICES Invacare Corp, Tracer Series, K9, K(935398 Electro kinetic Technologies, Breez 1025.1K(111095 Barton Medical, model I-1000, K(07 1793 4. DEVICE DESCRIPTION The Harris Medical RH 3500 Transport… | 2011 |
| * | K071793 | Convertible I-Series Positioning and Transfer ChairSummary page 3…ice was granted marketing clearance by the FDA on March 1" 1994, under 510OK number K 935398 and Electro kinetic Technologies KI 11095 and Barton Medical, K07 1793. 8. PERFORMANCE STANDARDS No performance standards applicable to this device have been adopted under Section 514 of… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
- 11 other devices also cite its predicate K935398.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, 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 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
The RH 3500 EZ 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 RH 3500 EZ 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/K130517 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130517: EZ Transport Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130517
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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