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 |
| K234029 |
CEFALY Technology |
CEFALY Connected - OTC, CEFALY Connected - Rx |
07/18/2024 |
| 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 |
| K242719 |
Nu Eyne Co., Ltd. |
ELEXIR 2.0 (ALLIVE3) |
11/06/2024 |
| K210364 |
Shenzhen Dongdixin Technology Co., Ltd. |
Migraine Tens Digital Pain Reliever |
06/17/2021 |
| K233751 |
Soterix Medical, Inc. |
Milieve (YPS-301BD) |
06/03/2024 |
| DEN120019 |
STX-MED SPRL |
CEFALY |
03/11/2014 |
| K172450 |
WAT Medical Technology (Ningbo) Co., Ltd |
TENS device-HeadaTerm, eEspress |
09/13/2018 |
| K230782 |
WAT Medical Technology Inc. |
TENS device-HeadaTerm 2 (Model: YF-HT2) |
02/26/2024 |
| K232749 |
Ybrain, Inc. |
DOOPANG |
06/11/2024 |
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