510(k) · Cleared
ClearedEkso™ (version 1.1) and Ekso GT™ (version 1.2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ekso Bionics, Inc. · PHL Powered Exoskeleton
Cleared on Jul 19, 2016 as substantially equivalent to K143690 (Ekso Bionics, Inc., 2016) after a 55-day review. Its family tree reaches back 2 generations to 2014. 12 later devices descend from it.
- Decided
- Jul 19, 2016
- Review
- 55 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130034 (2014). 12 later devices descend from it, 4 citing it directly.
- Root · 2 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 1 generation backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- This deviceK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK171334 IndegoParker Hannifin Corporation · 2017
- Descendant · cites it directly · 5 of its ownK173530 Indego (R)Parker-Hannifin Corporation · 2018
- Descendant · 2 generations on · 3 of its ownK221859 AtalanteWandercraft SAS · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK232077 Atalante XWandercraft SAS · 2023
- Descendant · cites it directly · 2 of its ownK181294 Honda Walking Assist DeviceHonda Motor Company, Ltd. · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K171334IndegoParker Hannifin Corporation · 2017 · cites it directly6descendants
- K173530Indego (R)Parker-Hannifin Corporation · 2018 · cites it directly5descendants
- K221859AtalanteWandercraft SAS · 2022 · 2 generations on3descendants
- K232077Atalante XWandercraft SAS · 2023 · 2 generations on2descendants
- K181294Honda Walking Assist DeviceHonda Motor Company, Ltd. · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −1 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| 0 (this device) | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| +1 | K171334 | Indego | Parker Hannifin Corporation | 2017 | — |
| +1 | K173530 | Indego (R) | Parker-Hannifin Corporation | 2018 | — |
| +2 | K221859 | Atalante | Wandercraft SAS | 2022 | 1 |
| +2 | K232077 | Atalante X | Wandercraft SAS | 2023 | — |
| +1 | K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Summary page 4…with a cane, crutch, or walker. Predicate Device Manufacturer 510(k) Date of Clearance Ekso Bionics K143690 4/1/2016 1 Table 1 - Compa… | 2016 |
What descends from it? (12)
See all 124 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 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171334 (Parker Hannifin Corporation, 2017) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K143690.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population: • Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm) • Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms) • Individuals…
Read the full statement (121 words)
The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population:
• Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm)
• Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)
• Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161443
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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