Duns Number:600484465
Device Description: Relivion is a non-invasive medical device. It transfers mild electrical pulses to branches 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.
Catalog Number
-
Brand Name
Relivion
Version/Model Number
RLV3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K212106,K212106
Product Code
PCC
Product Code Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Public Device Record Key
b57991af-8a4e-488d-8ad7-410c90abed04
Public Version Date
December 13, 2021
Public Version Number
1
DI Record Publish Date
December 05, 2021
Package DI Number
17290018393113
Quantity per Package
1
Contains DI Package
07290018393000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |