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Orpyx Custom Sensory Insole Refill

Orpyx · Model SI000010 · UDI-DI 10185571000516

IRN MNE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This package contains only the insoles and product documentation such as an Instruction for Use manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.

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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.