Orpyx Sensory Insoles

Basic Information

• Brand Name: Orpyx Sensory Insoles
• Primary DI: 10185571000332
• Version / Model: ORPYXSIV1
• Catalog Number: 10185571000332
• Company Name: Orpyx
• Labeler DUNS: 250917031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-07
• Public Version: 1
• Public Version Date: 2025-02-17
• Public Version Status: New
• Public Device Record Key: 78180ad6-80b1-4d15-8b8a-fa3a12004813

Device Description

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 for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRN	Device, Warning, Overload, External Limb, Powered	Physical Medicine	890.5575	2
OIZ	Foot Examination Tool For Inflammatory Changes	Physical Medicine	890.5050	1
MNE	Orthosis, Moldable, Supportive, Skin Protective	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61782	Pressure 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10185571000332	GS1