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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Origin Size 8 Template - 09348215074715

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable

Super Tray inner - Origin - 09348215039905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

KEEOGO - CLINICIAN KIT - 07540162060007

Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

Ekso - B1431200000

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

EksoNR - B168EKSONR0

EKSO BIONICS SYSTEM, Ekso NR
EKSO BIONICS, INC.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical

EksoGT - B168EKSOGT0

EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

Indego Therapy - M704501110001

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

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
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