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Orpyx Hub

Orpyx · Model OH000010 · UDI-DI 10185571000554

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

Description

The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a 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.