Orpyx SI Sensory Insoles 10185571000066

GUDID 10185571000066

The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smartphone with the Orpyx Sensory Insole mobile application. The device provides the user with notification, and enables the transfer of data to enable remote patient monitoring. The following is included: Digital Display - Charging accessories - Instructions for use manual

Orpyx

Wireless patient monitor/sensor reporting software, layperson-use

• Primary Device ID: 10185571000066
• NIH Device Record Key: cb027bc7-a13e-42e5-b8ce-a4c3bc94903a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orpyx SI Sensory Insoles
• Version Model Number: OSIDDV1
• Catalog Number: 10185571000066
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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	10185571000066 [Primary]

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: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [Orpyx SI Sensory Insoles]

• 18557100000045: Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technolo
• 10185571000066: The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The d