# K171334: Indego

- Pathway: 510(k) (Traditional)
- Applicant: Parker Hannifin Corporation
- Decided: Sep 8, 2017 after 123 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: 3 generations back to DEN130034 (2014). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152416: Indego, Parker Hannifin Corporation (2016) Summary page 5.
- K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2), Ekso Bionics, Inc. (2016) Summary page 5.

## Most influential descendants
- 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
- K260381: Eve (2026), 0 descendants 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 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. The Indego is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K171334
Methodology: https://510kreport.com/methodology