510(k) K234029
K234029 is an FDA 510(k) premarket notification submitted by Cefaly Technology for the device "CEFALY Connected - OTC, CEFALY Connected - Rx". The FDA issued a decision of Substantially Equivalent on July 18, 2024. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891. Cefaly Technology has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2024
- Date Received
- December 20, 2023
- Clearance Type
- Traditional
- 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.