510(k) · Cleared
ClearedIndego
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parker Hannifin Corporation · PHL Powered Exoskeleton
Cleared on Feb 26, 2016 as substantially equivalent to DEN130034 (Argo Medical Technologies, Inc., 2014) after a 184-day review. Its family tree reaches back 1 generation to 2014. 7 later devices descend from it.
- Decided
- Feb 26, 2016
- Review
- 184 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130034 (2014). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- This deviceK152416 IndegoParker Hannifin Corporation · 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 · 3 generations on · 1 of its ownK250904 Atalante XWandercraft SAS · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
- K250904Atalante XWandercraft SAS · 2025 · 3 generations on1descendant
View 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) | K152416 | Indego | Parker Hannifin Corporation | 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 | — |
| +3 | K250904 | Atalante X | Wandercraft SAS | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 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 |
|---|---|---|---|
| * | 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 |
What descends from it? (7)
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?
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 Indego® orthotically fits to the lower limbs and the trunk; the device 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 Indego is not intended for sports or stair climbing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152416: Indego.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152416
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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