| Primary Device ID | 10185571000516 |
| NIH Device Record Key | e333e76b-fad6-4598-90e8-fef761a79a8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orpyx Custom Sensory Insole Refill |
| Version Model Number | SI000010 |
| 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 | 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 |
| 10185571000509 - Orpyx Custom Sensory Insole System | 2025-06-27 The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications |
| 10185571000516 - Orpyx Custom Sensory Insole Refill | 2025-06-27Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This package contains only the insoles and product documentation such as an Instruction for Use manual.
The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression.
The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities.
Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices. |
| 10185571000516 - Orpyx Custom Sensory Insole Refill | 2025-06-27 Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This |
| 10185571000554 - Orpyx Hub | 2025-06-27 The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the O |
| 10185571000066 - Orpyx SI Sensory Insoles | 2025-02-17 The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smart |
| 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 |