Orpyx SI sensory insoles

GUDID 18557100000045

Orpyx SI sensory insoles are custom insoles embedded with powered limb overload warning technology intended for monitoring physiologic parameters, including plantar pressure and temperature. It provides the user with real-time, individualized cues for pressure offloading. it is intended to act as an adjunct to standard foot care, not a replacement.

Orpyx

Plantar pressure distribution detector

• Primary Device ID: 18557100000045
• NIH Device Record Key: aec5507f-3bd2-484a-b0f4-726e5184181e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orpyx SI sensory insoles
• Version Model Number: ORPYXSIV1
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18557100000045 [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: 2019-12-25
• Device Publish Date: 2019-12-17

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