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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NxSTEP Unweighing System, without Harness
BIODEX MEDICAL SYSTEMS, INC.
950-484
In Commercial Distribution

  • 00718175004845 ()
950-484

  • Mobile gait rehabilitation system, harness-support
NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
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-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
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
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954868 ()
  • 07290014954861 ()
STR-000136-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954311 ()
  • 17290014954318 ()
STR-000080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954625 ()
  • 17290014954622 ()
STR-901079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954618 ()
  • 17290014954615 ()
STR-901024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954601 ()
  • 17290014954608 ()
STR-009024-00

  • Depth electrode
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