# K152416: Indego

- Pathway: 510(k) (Traditional)
- Applicant: Parker Hannifin Corporation
- Decided: Feb 26, 2016 after 184 days
- Product code: PHL (Powered Exoskeleton)
- Device class: 2
- Regulation: 21 CFR 890.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130034 (2014). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130034: Rewalk, Argo Medical Technologies, Inc. (2014). 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. Summary page 5.

## Most influential descendants
- K171334: Indego (2017), 6 descendants of its own
- K173530: Indego (R) (2018), 5 descendants of its own
- K221859: Atalante (2022), 3 descendants of its own
- K232077: Atalante X (2023), 2 descendants of its own
- K250904: Atalante X (2025), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K152416
Methodology: https://510kreport.com/methodology