FDA 510(k) Applications for Medical Device Product Code "PCC"

FDA 510(k) Number Applicant Device Name Decision Date
K160237 CEFALY TECHNOLOGY Cefaly 03/04/2016
K171446 CEFALY Technology Cefaly Acute 09/15/2017
K201895 CEFALY Technology Cefaly Dual 09/29/2020
K173006 CEFALY Technology Cefaly Dual 11/28/2017
K212071 CEFALY Technology Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx 12/13/2022
K203419 Neurolief Ltd. Relivion 02/16/2021
K212106 Neurolief Ltd. Relivion 08/02/2021
K192773 Nu Eyne Co., Ltd ALLIVE 12/06/2019
K211380 Nu Eyne Co., Ltd. Elexir 07/30/2021
K210364 Shenzhen Dongdixin Technology Co., Ltd. Migraine Tens Digital Pain Reliever 06/17/2021
DEN120019 STX-MED SPRL CEFALY 03/11/2014
K172450 WAT Medical Technology (Ningbo) Co., Ltd TENS device-HeadaTerm, eEspress 09/13/2018


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