DEVICE: ExoAtlet®-II (18800140400031)

Device Identifier (DI) Information

ExoAtlet®-II
EAS010
In Commercial Distribution

COSMO ROBOTICS CO., Ltd.
18800140400031
GS1

1
694799633 *Terms of Use
The ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions, hospitals, or similar institutions under the supervision of a healthcare professional (HCP) such as a trained physical therapist. The ExoAtlet-II is indicated for individuals with spinal cord injuries at levels T4-L5 and individuals with spinal cord injuries at levels of C7-T3. All users must have upper extremity motor function of at least 4/5 in both arms. The ExoAtlet-II is intended for multiple users in a clinical setting (i.e., gait lab or rehabilitation center) under supervision. The ExoAtlet-II includes a battery powered exoskeleton, an ExoCrutch, and a Tablet PC. ExoAtlet-II is designed to be operated with a trained physical therapist who has received preliminary training on the Exoskeleton operation. This therapist will be familiar with the rules of the use and operational documentation. Training is conducted in a designated medical facility that is representative of the indicated environments (e.g., hospital, outpatient physical therapy clinic or similar). The training identifies safe environments of device use and uses all of the safety features found in the subject device. The training manual will be provided with the user manual along with a trainee itinerary and a trainee certification exam. The trainee needs to pass 80% of the exam questions to obtain certification.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

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?
58943 Programmable ambulation exoskeleton, clinical
A battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; 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) under healthcare professional supervision.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PHL Powered Exoskeleton
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K201473 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c795c60b-ed56-4672-b7e2-89296056aa86
February 03, 2025
2
January 17, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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