Orpyx Sensory Insoles 10185571000479

GUDID 10185571000479

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 - 6 months of RPM support - support for scanning, fitting and dispensing.

Orpyx

Pressure monitoring insole

• Primary Device ID: 10185571000479
• NIH Device Record Key: 32f36fbb-0943-44ba-876f-cbcb86538873
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orpyx Sensory Insoles
• Version Model Number: ORPYXSIV1
• Catalog Number: 10185571000479
• Company DUNS: 250917031
• Company Name: Orpyx
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10185571000479 [Primary]

FDA Product Code

• MNE: Orthosis, Moldable, Supportive, Skin Protective

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [Orpyx Sensory Insoles]

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