DEVICE: HAL for Medical Use (04560340090971)

Device Identifier (DI) Information

HAL for Medical Use
HAL-ML05-DXMUS
In Commercial Distribution

CYBERDYNE, INC.
04560340090971
GS1

1
714480766 *Terms of Use
Number of legs: Double Leg length: eXtra long Hip width: Medium
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
HCC Device, Biofeedback
PHL Powered Exoskeleton
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K171909 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fdf520ca-c236-4295-abfa-41915b2fbb33
March 04, 2019
1
February 01, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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