510(k) · Cleared
ClearedHonda Walking Assist Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Honda Motor Company, Ltd. · PHL Powered Exoskeleton
Cleared on Dec 14, 2018 as substantially equivalent to K161443 (Ekso Bionics, Inc., 2016) after a 212-day review. Its family tree reaches back 3 generations to 2014. 2 later devices descend from it.
- Decided
- Dec 14, 2018
- Review
- 212 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130034 (2014). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 2 generations backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 1 generation backK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- This deviceK181294 Honda Walking Assist DeviceHonda Motor Company, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK213452 GEMS-HSamsung Electronics Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK201539 Keeogo Dermoskeleton SystemB-Temia, Inc. · 2020
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 |
|---|---|---|---|---|---|
| −3 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −2 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| −1 | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| 0 (this device) | K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018 | — |
| +1 | K213452 | GEMS-H | Samsung Electronics Co., Ltd. | 2022 | — |
| +1 | K201539 | Keeogo Dermoskeleton System | B-Temia, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 PHL? 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 PHL device
- #1 K250904 Atalante Xscore 15.0 · 7 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 |
|---|---|---|---|
| * | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Summary page 5…Number Device Ekso™ (Version 1.1) & Ekso Bionics®, Inc. K161443 Ekso GT™ (Version 1.2) For simplicity, we will refer to the Ekso™ (Version 1.… | 2016 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213452 (Samsung Electronics Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K161443.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PHL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHL
177in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHL
6in 2025
MAUDE reports naming product code PHL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 4 | 145 | 0 | 4 |
| 2017 | 2 | — | 1 | 8 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 4 | 110 | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 3 | 177 | 0 | 2 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user’s waist and thigh, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutes under the supervision of a trained healthcare professional for the following population:
• Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the device. The devices are not intended for sports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181294: Honda Walking Assist Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181294
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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