510(k) · Cleared
ClearedHAL for Medical Use (Lower Limb Type)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberdyne, Inc. · PHL Powered Exoskeleton
Cleared on Dec 17, 2017 as substantially equivalent to DEN130034 (Argo Medical Technologies, Inc., 2014) after a 174-day review. Its family tree reaches back 1 generation to 2014. 3 later devices descend from it.
- Decided
- Dec 17, 2017
- Review
- 174 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130034 (2014). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- This deviceK171909 HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK201559 HAL for Medical Use (Lower Limb type)Cyberdyne, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK233695 Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK254198 Trexo TheoTrexo Robotics, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| 0 (this device) | K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | 2017 | — |
| +1 | K201559 | HAL for Medical Use (Lower Limb type) | Cyberdyne, Inc. | 2020 | — |
| +2 | K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | 2024 | — |
| +3 | K254198 | Trexo Theo | Trexo Robotics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | DEN130034 | Rewalk Our reading of the summary gave K131798, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130034, Rewalk (Argo Medical Technologies, Inc.), granted Jun 26, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
| † | K971708 | Physiological Monitoring & Biofeedback Training Device | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201559 | HAL for Medical Use (Lower Limb type) | 2020 | 2 |
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?
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. HAL is a gait training device intended to temporarily help improve ambulation upon…
Read the full statement (171 words)
HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171909: HAL for Medical Use (Lower Limb Type).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171909
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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