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Orpyx System
Orpyx System consisting of Orpyx Receiver, accessories (Orpyx Hub) and supporting product documentation. The Orpyx System consists of a powered limb overload warning system to provide real time alerts for pressure offloading. The Orpyx System is intended to act as an adjunct to standard foot care, not a replacement. It is designed for use throughout activities of daily living.
Details
Device typePressure monitoring insole: A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device.
FDA categoryDevice, Warning, Overload, External Limb, Powered
Device ID10185571000585
Catalog numberORPYXSYSTEM
AvailabilityPrescription
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information