Orpyx SI

GUDID 10185571000042

The Orpyx® SI 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 (pair) which wirelessly communicates with a display application running on a smartphone. 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 in the the Orpyx SI Start Up Kit - 1 pair of custom insoles - Charging accessories (cable and wall adapter - Instructions for use manual

Orpyx

Plantar pressure distribution detector Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit Plantar pressure/morphology assessment unit

• Primary Device ID: 10185571000042
• NIH Device Record Key: 34433e54-e9bb-48ec-87f8-8291935d4c59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orpyx SI
• Version Model Number: ORPYXSIV1 - Start Up Kit
• 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: true
• 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	10185571000042 [Primary]
GS1	18557100000045 [Previous]

FDA Product Code

• IRN: Device, Warning, Overload, External Limb, Powered

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: 2020-05-04
• Device Publish Date: 2020-04-26

On-Brand Devices [Orpyx SI]

• 10185571000127: The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. Th
• 10185571000059: The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. Th
• 10185571000042: The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. Th