Duns Number:250917031
Device Description: The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceratio The Orpyx® SI sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom 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 for remote monitoring purposes. The following items are included in the ORPYXSIV1 - Insoles package: - 1 pair custom insoles - Instruction for use manual
Catalog Number
-
Brand Name
Orpyx SI
Version/Model Number
ORPYXSIV1 - Insoles
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRN
Product Code Name
Device, Warning, Overload, External Limb, Powered
Public Device Record Key
c96cdbf4-80a5-426a-bec1-92fc9ec5e2fd
Public Version Date
May 04, 2020
Public Version Number
1
DI Record Publish Date
April 26, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |