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Orpyx SI

Orpyx · Model ORPYXSIV1 - Start Up Kit with Digital Display · UDI-DI 10185571000127

IRNMNE Prescription
10
510(k) clearances
0
Adverse events
0
Recalls
1
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 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

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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.