SurroSense Rx System

GUDID 11855710000019

The SurroSense Rx system is a tool to help actively prevent the complications associated with peripheral neuropathy and track user progress. The system is comprised of sensor embedded inserts that are worn inside of running or walking shoes which communicate wirelessly to the Smartwatch. When dangerous time and pressure levels have been exceeded underfoot, an alerts is triggered on the Smartwatch. Subsequently, the user is to modify their behavior following offloading instructions provided on the Smartwatch.

Orpyx

Pressure monitoring insole

• Primary Device ID: 11855710000019
• NIH Device Record Key: 74a10501-ca02-468e-a49c-10b51362c1bb
• Commercial Distribution Discontinuation: 2019-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SurroSense Rx System
• Version Model Number: SSV1
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	11855710000019 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-10-10

Devices Manufactured by Orpyx

• 10185571000042 - Orpyx SI: 2020-05-04 The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure se
• 10185571000059 - Orpyx SI: 2020-05-04 The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure se
• 10185571000127 - Orpyx SI: 2020-05-04 The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure se
• 18557100000045 - Orpyx SI sensory insoles: 2019-12-25 Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physi
• 11855710000019 - SurroSense Rx System: 2019-12-18The SurroSense Rx system is a tool to help actively prevent the complications associated with peripheral neuropathy and track user progress. The system is comprised of sensor embedded inserts that are worn inside of running or walking shoes which communicate wirelessly to the Smartwatch. When dangerous time and pressure levels have been exceeded underfoot, an alerts is triggered on the Smartwatch. Subsequently, the user is to modify their behavior following offloading instructions provided on the Smartwatch.
• 11855710000019 - SurroSense Rx System: 2019-12-18 The SurroSense Rx system is a tool to help actively prevent the complications associated with peripheral neuropathy and track us