FDA UDI
In Commercial Distribution
🇺🇸 United States
Orpyx Custom Sensory Insole System
DI: 10185571000509
·
Model: SI000010
·
Orpyx
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orpyx Custom Sensory Insole System
- Primary DI
- 10185571000509
- Version / Model
- SI000010
- Company Name
- Orpyx
- Labeler DUNS
- 250917031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-19
- Public Version
- 1
- Public Version Date
- 2025-06-27
- Public Version Status
- New
- Public Device Record Key
- 72eed2c3-36ce-4c7f-964b-483ea292082b
Device Description
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. 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRN | Device, Warning, Overload, External Limb, Powered | Physical Medicine | 890.5575 | 2 |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61782 | Pressure monitoring insole | A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10185571000509 | GS1 |