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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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Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539018

The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton

Discovery NM 530c - 00840682105286

UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system

D630 Upgrade - 00840682145503

B615 to D630 upgrade kits option with new ROTOR
Hangwei GE Medical Systems Co., Ltd.
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system

NM - 00840682140829

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system

Discovery - 00840682139274

D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system

Brivo - 00840682139267

No Description
Hangwei GE Medical Systems Co., Ltd.
NM 615
In Commercial Distribution

  • 00840682139267 ()


  • Stationary gamma camera system

D750b - 00840682138758

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry UPG
In Commercial Distribution

  • 00840682138758 ()


  • Stationary gamma camera system

D750b - 00840682138741

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Biopsy
In Commercial Distribution

  • 00840682138741 ()


  • Stationary gamma camera system

D750b - 00840682138697

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
Gantry
In Commercial Distribution

  • 00840682138697 ()


  • Stationary gamma camera system

D630 Upgrade - 00840682123761

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


  • Stationary gamma camera system
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