De Novo · Granted
GrantedRewalk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argo Medical Technologies, Inc. · PHL Powered Exoskeleton
Granted on Jun 26, 2014 as a new device type through De Novo after a 374-day review. 20 later devices descend from it.
- Decided
- Jun 26, 2014
- Review
- 374 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
20 later devices descend from it, 3 citing it directly.
- This deviceDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- Descendant · cites it directly · 14 of its ownK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- Descendant · 2 generations on · 12 of its ownK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK152416 IndegoParker Hannifin Corporation · 2016
- Descendant · 2 generations on · 6 of its ownK171334 IndegoParker Hannifin Corporation · 2017
- Descendant · 2 generations on · 5 of its ownK173530 Indego (R)Parker-Hannifin Corporation · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016 · cites it directly14descendants
- K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016 · 2 generations on12descendants
- K152416IndegoParker Hannifin Corporation · 2016 · cites it directly7descendants
- K171334IndegoParker Hannifin Corporation · 2017 · 2 generations on6descendants
- K173530Indego (R)Parker-Hannifin Corporation · 2018 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| +1 | K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| +2 | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016 | — |
| +1 | K152416 | Indego | Parker Hannifin Corporation | 2016 | — |
| +2 | K171334 | Indego | Parker Hannifin Corporation | 2017 | — |
| +2 | K173530 | Indego (R) | Parker-Hannifin Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (20)
See all 203 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?
- Of its descendants, K143690 (Ekso Bionics, Inc., 2016) has gone furthest, with 14 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. 2014, 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 Argo ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN130034 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130034: Rewalk.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130034
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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