ExoAtlet®-II

Basic Information

• Brand Name: ExoAtlet®-II
• Primary DI: 18800140400031
• Version / Model: EAS010
• Company Name: COSMO ROBOTICS CO., Ltd.
• Labeler DUNS: 694799633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-17
• Public Version: 2
• Public Version Date: 2025-02-03
• Public Version Status: Update
• Public Device Record Key: c795c60b-ed56-4672-b7e2-89296056aa86

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHL	Powered Exoskeleton	Physical Medicine	890.3480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18800140400031	GS1

Premarket Submissions

Submission Number	Supplement Number
K201473	000