510(k) K212106
K212106 is an FDA 510(k) premarket notification submitted by Neurolief , Ltd. for the device "Relivion". The FDA issued a decision of Substantially Equivalent on August 2, 2021. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891. Neurolief , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2021
- Date Received
- July 6, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Device Class
- Class II
- Regulation Number
- 882.5891
- Review Panel
- NE
- Submission Type
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.