FDA UDI
In Commercial Distribution
🇺🇸 United States
Relivion
DI: 07290018393000
·
Model: RLV3
·
NEUROLIEF LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Relivion
- Primary DI
- 07290018393000
- Version / Model
- RLV3
- Company Name
- NEUROLIEF LTD
- Labeler DUNS
- 600484465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-05
- Public Version
- 2
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- b57991af-8a4e-488d-8ad7-410c90abed04
Device Description
Relivion is a non-invasive medical device. It transfers mild electrical pulses to branches of the Trigeminal (Supraorbital and Supratrochlear) and Occipital nerves to treat headaches.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | Neurology | 882.5891 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60682 | Craniofacial analgesia electrical stimulator | A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290018393113 | GS1 | Cardboard Box | 1 | In Commercial Distribution | |
| Primary | 07290018393000 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212106 | 000 |