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EKSO BIONICS SYSTEM, Ekso GT
Ekso Bionics, Inc.
EKSOGT
In Commercial Distribution
- B168EKSOGT0 ()
EKSOGT
- Programmable ambulation exoskeleton, clinical
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.
COSMO ROBOTICS CO., Ltd.
EAS010
In Commercial Distribution
- 18800140400031 ()
- Programmable ambulation exoskeleton, clinical
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution
- 07540162060007 ()
- Programmable ambulation exoskeleton, clinical
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
Ekso Bionics, Inc.
GT
In Commercial Distribution
- B1431200000 ()
- Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-110-001
In Commercial Distribution
- B168501110001 ()
- Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-100-000
In Commercial Distribution
- B168501100000 ()
- Programmable ambulation exoskeleton, clinical
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
592-409
In Commercial Distribution
- 09348215137854 ()
- Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution
- 09348215039905 ()
- Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7040
In Commercial Distribution
- 09348215087395 ()
- Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7030
In Commercial Distribution
- 09348215087388 ()
- Surgical implant template, reusable