FDA UDI
In Commercial Distribution
🇺🇸 United States
Orpyx Sensory Insoles
DI: 10185571000356
·
Model: ORPYXSIV1
·
Orpyx
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Orpyx Sensory Insoles
- Primary DI
- 10185571000356
- Version / Model
- ORPYXSIV1
- Catalog Number
- 10185571000356
- 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
- 95788e2c-a7ec-458e-b1af-210dcd95be24
Device Description
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support
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 |
| MNE | Orthosis, Moldable, Supportive, Skin Protective | Physical Medicine | 890.3475 | 1 |
| 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 | 10185571000356 | GS1 |