FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SurroSense Rx System
DI: 11855710000019
·
Model: SSV1
·
Orpyx
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SurroSense Rx System
- Primary DI
- 11855710000019
- Version / Model
- SSV1
- Company Name
- Orpyx
- Labeler DUNS
- 250917031
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 3
- Public Version Date
- 2019-12-18
- Public Version Status
- Update
- Public Device Record Key
- 74a10501-ca02-468e-a49c-10b51362c1bb
- Distribution End Date
- 2019-11-30
Device Description
The SurroSense Rx system is a tool to help actively prevent the complications associated with peripheral neuropathy and track user progress. The system is comprised of sensor embedded inserts that are worn inside of running or walking shoes which communicate wirelessly to the Smartwatch. When dangerous time and pressure levels have been exceeded underfoot, an alerts is triggered on the Smartwatch. Subsequently, the user is to modify their behavior following offloading instructions provided on the Smartwatch.
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
- No
- 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 |
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 | 11855710000019 | GS1 |