# K171909: HAL for Medical Use (Lower Limb Type)

- Pathway: 510(k) (Traditional)
- Applicant: Cyberdyne, Inc.
- Decided: Dec 17, 2017 after 174 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.
3 later devices descend from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K201559: HAL for Medical Use (Lower Limb type) (2020), 2 descendants of its own
- K233695: Medical HAL Lower Limb Type (HAL-ML) (2024), 1 descendant of its own
- K254198: Trexo Theo (2026), 0 descendants of its own

## Indications for use
HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy. In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

Source page: https://510kreport.com/device/K171909
Methodology: https://510kreport.com/methodology