Orpyx SI
Orpyx · Model ORPYXSIV1 - Insoles · UDI-DI 10185571000059
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 items are included in the ORPYXSIV1 - Insoles package: - 1 pair custom insoles - Instruction for use manual
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Get your free API keyRead the docsData 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.