# K233695: Medical HAL Lower Limb Type (HAL-ML)

- Pathway: 510(k) (Traditional)
- Applicant: Cyberdyne, Inc.
- Decided: May 7, 2024 after 172 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.
1 later device descends 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)
- K201559: HAL for Medical Use (Lower Limb type), Cyberdyne, Inc. (2020) Summary page 5.

## Most influential descendants
- K254198: Trexo Theo (2026), 0 descendants of its own

## Indications for use
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; 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. The device is intended for individuals with: - spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T1 1 to L5 (ASIA A with Zones of Partial Preservation, ASIA B); - post stroke paresis - paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) -cerebral palsy and are 12 years or older -spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. 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 healthcare facilities while under trained medical supervision in accordance with the user assessment and training certification program.

Source page: https://510kreport.com/device/K233695
Methodology: https://510kreport.com/methodology