# K201539: Keeogo Dermoskeleton System

- Pathway: 510(k) (Traditional)
- Applicant: B-Temia, Inc.
- Decided: Sep 9, 2020 after 92 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: 4 generations back to DEN130034 (2014). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181294: Honda Walking Assist Device, Honda Motor Company, Ltd. (2018) Summary page 4.

## Indications for use
The Keeogo is robotic exoskeleton that fits orthotically on the user's waist, thigh, and shin, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation settings under the supervision of a trained healthcare professional for the following population: Individuals with stroke who have gait deficits and sufficient hip (MMT Hip > 3) and knee strength (MMT Knee > 2) and who are capable of standing and initiating gait movement without assistance. The trained healthcare professional must successfully complete a training program prior to fitting and tuning the device. The device is not intended for sports.

Source page: https://510kreport.com/device/K201539
Methodology: https://510kreport.com/methodology