DEVICE: HAL for Medical Use (04560340091091)
Device Identifier (DI) Information
HAL for Medical Use
HAL-ML05-DXWUS
In Commercial Distribution
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution
CYBERDYNE, INC.
Number of legs: Double
Leg length: eXtra long
Hip width: Wide
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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63288 | Neuro-controlled ambulation exoskeleton |
A battery-powered, bionic, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function, via cutaneous electrodes, to the device motor assembly. It is intended to improve gait after use and may also be used in a pre-programmed configuration. The system includes an exoskeleton structure made of metal with electric motors and mechanical actuators; it is typically strapped to the legs over clothing. It is intended for multiple-patient use in a controlled clinical setting (e.g., gait lab, rehabilitation centre).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HCC | Device, Biofeedback |
PHL | Powered Exoskeleton |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
49ebb48f-249d-41ab-bbdc-26d84e7cf5be
May 11, 2022
2
February 01, 2019
May 11, 2022
2
February 01, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined