Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Regulation 882.5891
1510(k)s in 12 months (18 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PCC
| Company | 510(k)s | Recalls |
|---|---|---|
| Cefaly Technology | 6 | 0 |
| Nu Eyne Co., Ltd. | 3 | 0 |
| Neurolief , Ltd. | 2 | 0 |
| Hinge Health, Inc. | 1 | 0 |
| Shenzhen Dongdixin Technology Co., Ltd. | 1 | 0 |
| Soterix Medical, Inc. | 1 | 0 |
| Stx-Med Sprl | 1 | 0 |
| Wat Medical Technology, Inc. | 1 | 0 |
| Wat Medical Technology (Ningbo) Co., Ltd. | 1 | 0 |
| Ybrain, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 2026 | K254216 | Enso for Migraine Hinge Health, Inc. | PCC |
| Nov 6, 2024 | K242719 | ELEXIR 2.0 (ALLIVE3) Nu Eyne Co., Ltd., KR | PCC |
| Jul 18, 2024 | K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx Cefaly Technology, BE | PCC |
| Jun 11, 2024 | K232749 | DOOPANG Ybrain, Inc., KR | PCC |
| Jun 3, 2024 | K233751 | Milieve (YPS-301BD) Soterix Medical, Inc. | PCC |
| Feb 26, 2024 | K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) Wat Medical Technology, Inc., CN | PCC |
| Dec 13, 2022 | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Conn Cefaly Technology, BE | PCC |
| Aug 2, 2021 | K212106 | Relivion Neurolief , Ltd., IL | PCC |
| Jul 30, 2021 | K211380 | Elexir Nu Eyne Co., Ltd., KR | PCC |
| Jun 17, 2021 | K210364 | Migraine Tens Digital Pain Reliever Shenzhen Dongdixin Technology Co., Ltd., CN | PCC |
| Feb 16, 2021 | K203419 | Relivion Neurolief , Ltd., IL | PCC |
| Sep 29, 2020 | K201895 | Cefaly Dual Cefaly Technology, BE | PCC |
| Dec 6, 2019 | K192773 | ALLIVE Nu Eyne Co., Ltd., KR | PCC |
| Sep 13, 2018 | K172450 | TENS device-HeadaTerm, eEspress Wat Medical Technology (Ningbo) Co., Ltd., CN | PCC |
| Nov 28, 2017 | K173006 | Cefaly Dual Cefaly Technology, BE | PCC |
| Sep 15, 2017 | K171446 | Cefaly Acute Cefaly Technology, BE | PCC |
| Mar 4, 2016 | K160237 | Cefaly Cefaly Technology, BE | PCC |
| Mar 11, 2014 | DEN120019 | CEFALY Stx-Med Sprl, BE | PCC |
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