# K213452: GEMS-H

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Apr 21, 2022 after 177 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 GEMS-H is a robotic exoskeleton that fits orthotically on the wearer's waist and thighs, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutions 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 0.4 m/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 device is not intended for sports.

Source page: https://510kreport.com/device/K213452
Methodology: https://510kreport.com/methodology