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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 Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000349 ()
10185571000349

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000332 ()
10185571000332

  • Pressure monitoring insole
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000172 ()
10185571000172

  • Pressure monitoring insole
Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
ACCELERATED CARE PLUS CORP
300800A
In Commercial Distribution

  • 00858703006337 ()


  • Bioelectrical signal analysis software
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
Not in Commercial Distribution

  • 00850023296351 ()
Shoe insole size 4 (men 13.0 to 15.0)

  • Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (3)
Not in Commercial Distribution

  • 00850023296344 ()
Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)

  • Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2-3)
Not in Commercial Distribution

  • 00850023296337 ()
Shoe insole size (2-3) (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2)
Not in Commercial Distribution

  • 00850023296320 ()
Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 to 10.5)

  • Pressure monitoring insole
footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (12)
Not in Commercial Distribution

  • 00850023296313 ()
Shoe insole size (12) (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole
footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
Not in Commercial Distribution

  • 00850023296306 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)

  • Pressure monitoring insole
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