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Orpyx SI

Orpyx · Model ORPYXSIV1 - Start Up Kit · UDI-DI 10185571000042

IRN MNE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.