FDA Product Code
FDA Product Code PCC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5891
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254216 | Enso for Migraine | Hinge Health, Inc. | 2026-04-16 | Traditional | PDF ↗ |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | 2024-11-06 | Traditional | PDF ↗ |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024-07-18 | Traditional | PDF ↗ |
| K232749 | DOOPANG | Ybrain, Inc. | 2024-06-11 | Traditional | PDF ↗ |
| K233751 | Milieve (YPS-301BD) | Soterix Medical, Inc. | 2024-06-03 | Traditional | PDF ↗ |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. | 2024-02-26 | Traditional | PDF ↗ |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | Cefaly Technology | 2022-12-13 | Traditional | PDF ↗ |
| K212106 | Relivion | Neurolief , Ltd. | 2021-08-02 | Special | PDF ↗ |
| K211380 | Elexir | Nu Eyne Co., Ltd. | 2021-07-30 | Traditional | PDF ↗ |
| K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 | Traditional | PDF ↗ |
| K203419 | Relivion | Neurolief , Ltd. | 2021-02-16 | Traditional | PDF ↗ |
| K201895 | Cefaly Dual | Cefaly Technology | 2020-09-29 | Traditional | PDF ↗ |
| K192773 | ALLIVE | Nu Eyne Co., Ltd. | 2019-12-06 | Traditional | PDF ↗ |
| K172450 | TENS device-HeadaTerm, eEspress | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-09-13 | Traditional | PDF ↗ |
| K173006 | Cefaly Dual | Cefaly Technology | 2017-11-28 | Traditional | PDF ↗ |
| K171446 | Cefaly Acute | Cefaly Technology | 2017-09-15 | Traditional | PDF ↗ |
| K160237 | Cefaly | Cefaly Technology | 2016-03-04 | Special | PDF ↗ |
| DEN120019 | CEFALY | Stx-Med Sprl | 2014-03-11 | Post-NSE | — |
Product code PCC · Class II · Neurology. Data: openFDA.