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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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SurroSense Rx System - 11855710000019

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

MyoVision Software - 00853818007477

Software
PRECISION BIOMETRICS INC
Feature Pack H
In Commercial Distribution

  • 00853818007477 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007392

Software
PRECISION BIOMETRICS INC
Feature Pack G
In Commercial Distribution

  • 00853818007392 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007101

Software
PRECISION BIOMETRICS INC
Feature Pack E
In Commercial Distribution

  • 00853818007101 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007095

Software
PRECISION BIOMETRICS INC
Feature Pack D
In Commercial Distribution

  • 00853818007095 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007088

Software
PRECISION BIOMETRICS INC
Feature Pack C
In Commercial Distribution

  • 00853818007088 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007071

Software
PRECISION BIOMETRICS INC
Feature Pack B
In Commercial Distribution

  • 00853818007071 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007064

Software
PRECISION BIOMETRICS INC
Feature Pack A
In Commercial Distribution

  • 00853818007064 ()


  • Bioelectrical signal analysis software

MyoVision Software - 00853818007057

Software
PRECISION BIOMETRICS INC
Apricot
In Commercial Distribution

  • 00853818007057 ()


  • Bioelectrical signal analysis software

ABPM pro basic device - 04250413405640

No Description
SOMNOmedics AG
ABP050U
In Commercial Distribution

  • 04250413405640 ()


  • Blood pressure ambulatory recorder
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