Identity
- Trade Name
- Relivion MG PMI Physician Interface FDA UDI
- Generic Name
- Configurable electronic form web-based application software FDA UDI
- Device Name
- A cloud-based Patient Management Interface (PMI Physician Interface and cloud platform) FDA UDI
- Model / Reference
- RLV-PMI-101 FDA UDI
- Description
- A cloud-based Patient Management Interface (PMI Physician Interface and cloud platform) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018393130 FDA UDI
- 510(k) Number
- K212106 FDA UDI
- FDA Product Code
- PCC FDA UDI
- GMDN Term
- Configurable electronic form web-based application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5891 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Configurable electronic form web-based application software
Relivion MG PMI Physician Interface by Neurolief , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212106 also covers:
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
- Neurolief , Ltd.
Sources (1)
- FDA UDI 1692b0de-5381-4122-ad2f-9bf4a5b19cf3 34 fields · synced May 30, 2026