FDA UDI
In Commercial Distribution
🇺🇸 United States
Orpyx Flex Sensory Insoles
DI: 10185571000172
·
Model: ORPYXSIV1
·
Orpyx
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orpyx Flex Sensory Insoles
- Primary DI
- 10185571000172
- Version / Model
- ORPYXSIV1
- Catalog Number
- 10185571000172
- Company Name
- Orpyx
- Labeler DUNS
- 250917031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-07
- Public Version
- 1
- Public Version Date
- 2025-02-17
- Public Version Status
- New
- Public Device Record Key
- f2c41564-8608-4fc2-815c-479a9f00b7a8
Device Description
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
| OIZ | Foot Examination Tool For Inflammatory Changes | Physical Medicine | 890.5050 | 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 | 10185571000172 | GS1 |