510(k) Report

Devices descending from DEN120019

17 later devices reach Cefaly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172450TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd.20181—
+1K160237CefalyCefaly Technology201616—
+2K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.20240—
+2K192773AlliveNu Eyne Co., Ltd.20190—
+2K173006Cefaly DualCefaly Technology201710—
+2K171446Cefaly AcuteCefaly Technology201713—
+3K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…Cefaly Technology20222—
+3K211380ElexirNu Eyne Co., Ltd.20211—
+3K203419RelivionNeurolief, Ltd.20211—
+3K201895Cefaly DualCefaly Technology20207—
+4K242719Elexir 2.0 (ALLIVE3)Nu Eyne Co., Ltd.20240—
+4K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology20241—
+4K232749DoopangYbrain, Inc.20240—
+4K233751Milieve (YPS-301BD)Soterix Medical, Inc.20240—
+4K212106RelivionNeurolief, Ltd.20210—
+4K210364Migraine Tens Digital Pain RelieverShenzhen Dongdixin Technology Co., Ltd.20210—
+5K254216Enso for MigraineHinge Health, Inc.20260—