510(k) · Cleared
ClearedMedical HAL Lower Limb Type (HAL-ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberdyne, Inc. · PHL Powered Exoskeleton
Cleared on May 7, 2024 as substantially equivalent to K201559 (Cyberdyne, Inc., 2020) after a 172-day review. Its family tree reaches back 3 generations to 2014. 1 later device descends from it.
- Decided
- May 7, 2024
- Review
- 172 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN130034 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 2 generations backK171909 HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. · 2017
- 1 generation backK201559 HAL for Medical Use (Lower Limb type)Cyberdyne, Inc. · 2020
- This deviceK233695 Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK254198 Trexo TheoTrexo Robotics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254198Trexo TheoTrexo Robotics, Inc. · 2026 · cites it directly0descendants
View 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 | K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | 2017 | — |
| −1 | K201559 | HAL for Medical Use (Lower Limb type) | Cyberdyne, Inc. | 2020 | — |
| 0 (this device) | K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | 2024 | — |
| +1 | K254198 | Trexo Theo | Trexo Robotics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K201559 | HAL for Medical Use (Lower Limb type)Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201559 HAL for Medical Use (Lower Limb Type)… | 2020 |
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 |
|---|---|---|---|
| K254198 | Trexo Theo | 2026 | 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 10 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K254198 (Trexo Robotics, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; 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. The device is intended for individuals with: - spinal cord…
Read the full statement (227 words)
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk;
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.
The device is intended for individuals with:
- spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T1 1 to L5 (ASIA A with Zones of Partial
Preservation, ASIA B);
- post stroke paresis
- paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar
muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular
dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy)
-cerebral palsy and are 12 years or older
-spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic
paraplegia (HSP)
who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger
and control HAL.
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 healthcare 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/K233695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233695: Medical HAL Lower Limb Type (HAL-ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233695
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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