CEFALY
FDA 510(k) clearance DEN120019 · decided 2014-03-11
Clearance details
- K-number
- DEN120019
- Device name
- CEFALY
- Applicant
- Stx-Med Sprl
- Decision
- Unknown
- Date received
- 2012-12-13
- Decision date
- 2014-03-11
- Days to decision
- 453 days
- Clearance type
- Post-NSE
- Product code
- PCC
- Device class
- 2
- Regulation number
- 882.5891
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Herstal, Liege, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Enso for Migraine (K254216) | Hinge Health, Inc. | 2026-04-16 |
| ELEXIR 2.0 (ALLIVE3) (K242719) | Nu Eyne Co., Ltd. | 2024-11-06 |
| CEFALY Connected - OTC, CEFALY Connected - Rx (K234029) | Cefaly Technology | 2024-07-18 |
| DOOPANG (K232749) | Ybrain, Inc. | 2024-06-11 |
| Milieve (YPS-301BD) (K233751) | Soterix Medical, Inc. | 2024-06-03 |
| TENS device-HeadaTerm 2 (Model: YF-HT2) (K230782) | Wat Medical Technology, Inc. | 2024-02-26 |
| Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (K212071) | Cefaly Technology | 2022-12-13 |
| Relivion (K212106) | Neurolief , Ltd. | 2021-08-02 |
| Elexir (K211380) | Nu Eyne Co., Ltd. | 2021-07-30 |
| Migraine Tens Digital Pain Reliever (K210364) | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 |
| Relivion (K203419) | Neurolief , Ltd. | 2021-02-16 |
| Cefaly Dual (K201895) | Cefaly Technology | 2020-09-29 |
Recalls involving this device
No recalls on record reference this clearance.