Device Description : The Orpyx® SI sensory insole system is designed to help patients at risk of foot The Orpyx® SI 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 (pair) which wirelessly communicates with a display application running on a smartphone. 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 in the the Orpyx SI Start Up Kit- 1 pair of custom insoles- Charging accessories (cable and wall adapter- Instructions for use manual
Device Class : 1
Duns Number: 250917031
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Orpyx® SI sensory insole system is designed to help patients at risk of foot The Orpyx® SI 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 items are included in the ORPYXSIV1 - Insoles package: - 1 pair custom insoles - Instruction for use manual
Device Class : 1
Duns Number: 250917031
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Orpyx® SI sensory insole system is designed to help patients at risk of foot The Orpyx® SI 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 in the Orpyx SI Start Up Kit with Digital Display:- 1 pair of custom insoles- Digital Display- Charging accessories- Instructions for use manual
Device Class : 1
Duns Number: 250917031
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SurroSense Rx system is a tool to help actively prevent the complications as 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.
Device Class : 2
Duns Number: 250917031
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Orpyx SI sensory insoles are custom insoles embedded with powered limb overload Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and temperature. It provides the user with real-time, individualized cues for pressure offloading. it is intended to act as an adjunct to standard foot care, not a replacement.
Device Class : 1
Duns Number: 250917031
Premarket Exempt : Yes
Prescription Use : Yes