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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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