Identity
- Trade Name
- Orpyx SI Sensory Insoles FDA UDI
- Generic Name
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
- Device Name
- The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smartphone with the Orpyx Sensory Insole mobile application. The device provides the user with notification, and enables the transfer of data to enable remote patient monitoring. The following is included: Digital Display - Charging accessories - Instructions for use manual FDA UDI
- Model / Reference
- OSIDDV1 FDA UDI
- Description
- The Orpyx Sensory Insole Digital Display is part of the the Orpyx® sensory insole system. The digital display is a locked smartphone with the Orpyx Sensory Insole mobile application. The device provides the user with notification, and enables the transfer of data to enable remote patient monitoring. The following is included: Digital Display - Charging accessories - Instructions for use manual FDA UDI
Identifiers
- Catalog Number
- 10185571000066 FDA UDI
- Primary DI / UDI-DI
- 10185571000066 FDA UDI
- FDA Product Code
- IRN FDA UDI
- GMDN Term
- Wireless patient monitor/sensor reporting software, layperson-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5575 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wireless patient monitor/sensor reporting software, layperson-use
Orpyx SI Sensory Insoles by Orpyx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wireless patient monitor/sensor reporting software, layperson-use.
- TempTraq® — Blue Spark Technologies, Inc. · Class II
- OPSB Sensor Web Portal — Boston Brace International, Inc. · Class I
- SMART TSF — Smith & Nephew, Inc. · Class II
- Vital Sync — Covidien LP · Class II
- OPSB Sensor Cloud Backend — Boston Brace International, Inc. · Class I
- OPSB Sensor — Boston Brace International, Inc. · Class I
- OPSB Sensor Mobile App — Boston Brace International, Inc. · Class I
- Vital Sync — Covidien LP · 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 |
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Manufacturer
- Manufacturer
- Orpyx
Sources (1)
- FDA UDI cb027bc7-a13e-42e5-b8ce-a4c3bc94903a 34 fields · synced Jun 8, 2026