510(k) · Cleared
ClearedWalk on Wheels HS-3500 Electric Aisle Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walk on Wheels Australia Pty, Ltd. · ITI Wheelchair, Powered
Cleared on Sep 19, 2012 as substantially equivalent to K071006 (Heartway Medical Products Co., Ltd., 2007) after a 223-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Sep 19, 2012
- Review
- 223 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022697 (2003). No later device cites it as a predicate yet.
- 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 deviceK120405 Walk on Wheels HS-3500 Electric Aisle WheelchairWalk on Wheels Australia Pty, Ltd. · 2012
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) | K120405 | Walk on Wheels HS-3500 Electric Aisle Wheelchair | Walk on Wheels Australia Pty, Ltd. | 2012 | — |
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…wheelchair Classification name: Wheelchair, powered, ITI 3. Legally Marketed Predicate Device: HEARTWVAY Attendant-Controlled Power Chair, TC I, K071006 4. Device Description: The Walk on Wheels HD-3500 Electric Aisle Wheelchair is a power wheelchair designed… | 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 9 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.
- 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. 2012, 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 Walk on Wheels HS-3500 Electric Aisle Wheelchair is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person on/off an airplane or within the airport terminal. It is also suited for use in other narrow constrained spaces. it is not intended to be used during flight.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120405: Walk on Wheels HS-3500 Electric Aisle Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120405
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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