The Orpyx® Custom 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…
The Orpyx® Custom 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 to enable remote monitoring. The following is included: 1 pair of custom insoles – Digital Display – Charging accessories – Instructions for use manual – 12 months of RPM support – support for scanning, fitting and dispensing.
Who Else Makes It
Concentrated in Shanghai (2), Henan (2), Guangdong (2).
Record
Regulatory record for Orpyx Sensory Insoles | Listed by | Orpyx Medical Technologies Inc., Canada |
| FDA product code | MNE |
| Device type | Orthosis, Moldable, Supportive, Skin Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-07 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.