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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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The SurroSense Rx system is a tool to help actively prevent the complications associated with peripheral neuropathy and track user progress. The system is comprised of sensor embedded inserts that are worn inside of running or walking shoes which communicate wirelessly to the Smartwatch. When dangerous time and pressure levels have been exceeded underfoot, an alerts is triggered on the Smartwatch. Subsequently, the user is to modify their behavior following offloading instructions provided on the Smartwatch.
Orpyx
SSV1
Not in Commercial Distribution

  • 11855710000019 ()


  • Pressure monitoring insole
Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P15
In Commercial Distribution

  • 00869732000166 ()


  • Bioelectrical signal analysis software
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software
Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P14
In Commercial Distribution

  • 00869732000128 ()


  • Bioelectrical signal analysis software
Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P13
In Commercial Distribution

  • 00869732000111 ()


  • Bioelectrical signal analysis software
Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P12
In Commercial Distribution

  • 00869732000104 ()


  • Bioelectrical signal analysis software
No Description
Natus Medical Denmark ApS
Patient Responder (Grey)
Not in Commercial Distribution

  • 05713315000737 ()


  • Tone audiometer
No Description
Natus Medical Denmark ApS
Patient Responder (Blue)
Not in Commercial Distribution

  • 05713315000720 ()


  • Tone audiometer
No Description
Natus Medical Denmark ApS
Patient Responder (Red)
Not in Commercial Distribution

  • 05713315000713 ()


  • Tone audiometer
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