Cefaly®
Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use: CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per…
Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA – cleared device Indications for Use: CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY DUAL Enhanced is indicated to be used for: The acute treatment of migraine with or without aura in patients 18 years of age or older. The preventative treatment of episodic migraine in patients 18 years of age or older.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| WAT Medical Technology Inc. | Ningbo | Zhejiang | Repacker / relabeller | 4 |
Record
| Listed by | Cefaly Technology Sprl |
|---|---|
| FDA product code | PCC |
| Device type | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5891 |
| 510(k) | K201895 |
| Record published | 2021-07-13 |
| Record revised | 2019-03-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -20 to 45 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 11302 | 3 | In distribution | |
| CEFALY DUAL Enhanced | In distribution | ||
| CEFALY Enhanced | In distribution | ||
| 11201 | 3 | In distribution | |
| CEFALY Connected | In distribution | ||
| 11106 | 3 | In distribution | |
| 11202 | 3 | In distribution | |
| Acute | In distribution | ||
| Prevent | In distribution | ||
| CEFALY Connected Bundle VA | In distribution | ||
| 11301 | 3 | In distribution | |
| 11101 | 3 | In distribution | |
| 10205 | In distribution | ||
| Dual | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HeadaTerm | WAT Medical Technology Inc. | 3 |
| Relivion | Neurolief Inc. | 2 |
| Allive | NU Eyne Co., Ltd. | 1 |
| Elexir | NU Eyne Co., Ltd. | 1 |
| Relivion MG App | Neurolief Inc. | 1 |
| Tens 7000 | Drive DeVilbiss Healthcare | 1 |
| Doopang | Ybrain Inc. | 1 |
| Relivion MG PMI Physician Interface | Neurolief Inc. | 1 |
| Enso | Hinge Health Inc. | 1 |
| AccuRelief | Drive DeVilbiss Healthcare | 1 |
| Elexir 2.0 | NU Eyne Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.