510(k) Report

Devices descending from K212071

2 later devices reach Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology20241—
+2K254216Enso for MigraineHinge Health, Inc.20260—