510(k) Report

Devices descending from K201895

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232749DoopangYbrain, Inc.20240—
+1K233751Milieve (YPS-301BD)Soterix Medical, Inc.20240—
+1K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.20240—
+1K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…Cefaly Technology20222—
+1K210364Migraine Tens Digital Pain RelieverShenzhen Dongdixin Technology Co., Ltd.20210—
+2K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology20241—
+3K254216Enso for MigraineHinge Health, Inc.20260—