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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 consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
SI000010
In Commercial Distribution

  • 10185571000509 ()


  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support - 3rd party contracted scanning, fitting and dispensing support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000493 ()
10185571000493

  • 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 to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000486 ()
10185571000486

  • 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 to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000479 ()
10185571000479

  • 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 to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000462 ()
10185571000462

  • 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 to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000417 ()
10185571000417

  • Pressure monitoring insole
Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: pre-fabricated sensory insoles - instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000400 ()
10185571000400

  • Pressure monitoring insole
Orpyx Custom Sensory Insoles refill (1 pair) - This is a set of custom sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: Pair of custom sensory insoles - instructions for use manual.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000363 ()
10185571000363

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000356 ()
10185571000356

  • 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 - 6 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000349 ()
10185571000349

  • Pressure monitoring insole
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