510(k) K212071

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx by Cefaly Technology — Product Code PCC

K212071 is an FDA 510(k) premarket notification submitted by Cefaly Technology for the device "Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx". The FDA issued a decision of Substantially Equivalent on December 13, 2022. 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.