HAL-ML Lower Limb Type
by Cyberdyne, Inc. Japan EUDAMED510(k)
510(k) K233695
Product code PHL
Overview
The HAL-ML Lower Limb Type is a Powered Exoskeleton designed for physical medicine applications. It assists lower limb movement by interfacing with the user’s nervous system to restore or enhance gait function in individuals with neurological or neuromuscular impairments, including spinal cord injury, stroke, cerebral palsy, or related disorders.
This device is supplied as a wearable exoskeleton system, intended for use in clinical rehabilitation settings under medical supervision. It is classified as a Class II medical device under FDA regulations (890.3480) and has received FDA 510K clearance and MDR compliance. The system requires prescription and professional oversight for operation, with multiple registration numbers (e.g., 3015000676) reflecting its regulatory approvals in the U.S. and EU.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK233695 | Date7 May 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- Full name
- Medical HAL Lower Limb Type (HAL-ML)
- 510(k) Number
- FDA Product Code
- PHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3480
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cyberdyne, Inc.
Questions
What types of neurological or neuromuscular conditions is the HAL-ML Lower Limb Type designed to assist with during rehabilitation?
The HAL-ML Lower Limb Type is specifically designed to assist individuals with lower limb movement impairments caused by neurological or neuromuscular conditions such as spinal cord injury, stroke, cerebral palsy, or related disorders. It interfaces with the user’s nervous system to restore or enhance gait function in clinical rehabilitation settings under medical supervision.
Is the HAL-ML Lower Limb Type intended for home use or must it be used in a clinical setting?
The HAL-ML is intended exclusively for use in clinical rehabilitation settings under medical supervision. It is not designed for home use, as it requires professional oversight for operation and is classified as a powered exoskeleton for controlled therapeutic applications.
How is the HAL-ML Lower Limb Type supplied, and what does a typical order include?
The HAL-ML is supplied as a wearable exoskeleton system, meaning it comes as a complete, ready-to-use unit for clinical settings. While the exact components of a typical order are not detailed, it is a standalone device requiring no additional hardware beyond its own infrastructure, designed for direct use in rehabilitation therapy.
Does the HAL-ML Lower Limb Type require prescription or professional oversight for use?
Yes, the HAL-ML Lower Limb Type requires a prescription and professional oversight for operation. This is explicitly stated in its regulatory documentation, ensuring safe and controlled use in clinical rehabilitation settings.
What regulatory approvals does the HAL-ML Lower Limb Type hold in the U.S. and EU?
In the U.S., the HAL-ML has received FDA 510K clearance and is classified as a Class II medical device under FDA regulations (890.3480). In the EU, it complies with MDR (Medical Device Regulation) and holds multiple registration numbers (e.g., 3015000676) reflecting its approvals in both regions.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K233695
- EUDAMED