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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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No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution

  • 00860011850922 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution

  • 00860011850915 ()


  • Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution

  • 00860011850908 ()


  • Cognitive assessment software
NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is designed to address a patient’s difficulty with eye movement and the integration of visual information. The therapy re-trains the patient’s ability to scan the environment, re-integrate left and right vision, and make the most of their remaining visual field. NeuroeyeCoach is self-adaptive and adjusts the task difficulty to the patient's deficit and stage of recovery while encouraging eye movement efficiency.
Novavision, Inc.
NEC 2.00
In Commercial Distribution

  • 00860010599716 ()


  • Vision training software
VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
Novavision, Inc.
VRT 7.0
In Commercial Distribution

  • 00860010599709 ()


  • Vision training software
No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution

  • 00860009693401 ()


  • Cognitive assessment software
CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.
CNS Vital Signs, LLC
1.1.4
In Commercial Distribution

  • 00860013886134 ()


  • Psychological assessment software
CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in office or remotely.
CNS Vital Signs, LLC
2.0.6
In Commercial Distribution

  • 00860013886103 ()


  • Psychological assessment software
Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes. The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
Neurotrack Technologies, Inc.
1.1.0
In Commercial Distribution

  • 00860009484504 ()


  • Cognitive assessment software
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