# K181294: Honda Walking Assist Device

- Pathway: 510(k) (Traditional)
- Applicant: Honda Motor Company, Ltd.
- Decided: Dec 14, 2018 after 212 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). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K213452: GEMS-H (2022), 0 descendants of its own
- K201539: Keeogo Dermoskeleton System (2020), 0 descendants of its own

## Indications for use
The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user’s waist and thigh, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutes under the supervision of a trained healthcare professional for the following population: • Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meters with assistance from a maximum of one person. The trained healthcare professional must successfully complete a training program prior to use of the device. The devices are not intended for sports.

Source page: https://510kreport.com/device/K181294
Methodology: https://510kreport.com/methodology