510(k) · Cleared
ClearedIndego (R)
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 Jan 31, 2018 as substantially equivalent to K152416 (Parker Hannifin Corporation, 2016) and 2 other predicates after a 77-day review. Its family tree reaches back 4 generations to 2014. 5 later devices descend from it.
- Decided
- Jan 31, 2018
- Review
- 77 days
- Class
- Class II
- Product code
- PHL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to DEN130034 (2014). 5 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backDEN130034 RewalkArgo Medical Technologies, Inc. · 2014
- 3 generations backK143690 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 2 generations backK161443 Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. · 2016
- 1 generation backK171334 IndegoParker Hannifin Corporation · 2017
- This deviceK173530 Indego (R)Parker-Hannifin Corporation · 2018
- Descendant · cites it directly · 3 of its ownK221859 AtalanteWandercraft SAS · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK232077 Atalante XWandercraft SAS · 2023
- Descendant · 2 generations on · 1 of its ownK250904 Atalante XWandercraft SAS · 2025
- Descendant · cites it directly · 0 of its ownK260381 EveWandercraft SAS · 2026
- Descendant · cites it directly · 0 of its ownK190337 ReWalk RestoreRe Walk Robotics, Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K221859AtalanteWandercraft SAS · 2022 · cites it directly3descendants
- K232077Atalante XWandercraft SAS · 2023 · cites it directly2descendants
- K250904Atalante XWandercraft SAS · 2025 · 2 generations on1descendant
- K260381EveWandercraft SAS · 2026 · cites it directly0descendants
- K190337ReWalk RestoreRe Walk Robotics, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN130034 | Rewalk | Argo Medical Technologies, Inc. | 2014 | — |
| −3 | 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 | K171334 | Indego | Parker Hannifin Corporation | 2017 | — |
| 0 (this device) | K173530 | Indego (R) | Parker-Hannifin Corporation | 2018 | — |
| +1 | K221859 | Atalante | Wandercraft SAS | 2022 | 1 |
| +1 | K232077 | Atalante X | Wandercraft SAS | 2023 | — |
| +2 | K250904 | Atalante X | Wandercraft SAS | 2025 | — |
| +1 | K260381 | Eve | Wandercraft SAS | 2026 | — |
| +1 | K190337 | ReWalk Restore | Re Walk Robotics, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K152416 | IndegoSummary page 5…ss II Classification Panel: Neurology Page 1 of 12 5. Legally Marketed Predicate Devices K152416/K171334, Indego®, Parker Hannifin Corporation K161443, Ekso™, Ekso Bionics 6. Device Description Parker Hannifin’s Indego… | 2016 |
| * | K171334 | IndegoSummary page 5…Classification Panel: Neurology Page 1 of 12 5. Legally Marketed Predicate Devices K152416/K171334, Indego®, Parker Hannifin Corporation K161443, Ekso™, Ekso Bionics 6. Device Description Parker Hannifin’s Indego® device… | 2017 |
| * | K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Summary page 5…Page 1 of 12 5. Legally Marketed Predicate Devices K152416/K171334, Indego®, Parker Hannifin Corporation K161443, Ekso™, Ekso Bionics 6. Device Description Parker Hannifin’s Indego® device is a wearable powered exoskeleton that actively a… | 2016 |
What descends from it? (5)
4 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 4 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K221859 (Wandercraft SAS, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K152416.
How does its category compare?
All PHL devicesPHL Powered Exoskeleton: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 T3 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 C7 to L5 to perform ambulatory functions in rehabilitation…
Read the full statement (136 words)
The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 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 C7 to L5 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) 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/K173530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173530: Indego (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173530
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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