Identity
- Trade Name
- Orpyx Sensory Insoles FDA UDI
- Generic Name
- Pressure monitoring insole FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- ORPYXSIV1 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 10185571000356 FDA UDI
- Primary DI / UDI-DI
- 10185571000356 FDA UDI
- FDA Product Code
- IRN FDA UDIMNE FDA UDIOIZ FDA UDI
- GMDN Term
- Pressure monitoring insole FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5575 FDA UDI890.3475 FDA UDI890.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pressure monitoring insole
Orpyx Sensory Insoles by Orpyx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure monitoring insole.
- STEPRITE — MEDHAB, LLC · Class II
- STEPRITE — MEDHAB, LLC · Class II
- FeetMe Monitor FTM-DK — FEETME · Class I
- FeetMe Monitor FTM-DK — FEETME · Class I
- STEPRITE — MEDHAB, LLC · Class II
- STEPRITE — MEDHAB, LLC · Class II
- STEPRITE — MEDHAB, LLC · Class II
- STEPRITE — MEDHAB, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orpyx
Sources (1)
- FDA UDI 95788e2c-a7ec-458e-b1af-210dcd95be24 34 fields · synced May 30, 2026