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

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• 10185571000172 - Orpyx Flex Sensory Insoles: 2025-02-17 The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure
• 10185571000196 - Orpyx Sensory Insoles: 2025-02-17 Orpyx Sensory Insoles wireless charger and wall adapter replacement which is part of Orpyx Sensory Insole system. The charger en
• 10185571000332 - Orpyx Sensory Insoles: 2025-02-17 The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressur
• 10185571000349 - Orpyx Sensory Insoles: 2025-02-17 The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressur
• 10185571000356 - Orpyx Sensory Insoles: 2025-02-17 The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support
• 10185571000363 - Orpyx Sensory Insoles: 2025-02-17 Orpyx Custom Sensory Insoles refill (1 pair) - This is a set of custom sensory insoles compatible with the Orpyx Sensory Insole
• 10185571000400 - Orpyx Sensory Insoles: 2025-02-17 Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory I