Cefaly® 10601
GUDID 05425018850273
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.
Cefaly Technology SPRL
Craniofacial analgesia electrical stimulator| Primary Device ID | 05425018850273 |
| NIH Device Record Key | ff92c926-fe58-4f4b-bf24-a57b7e3df6a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cefaly® |
| Version Model Number | CEFALY DUAL Enhanced |
| Catalog Number | 10601 |
| Company DUNS | 762450752 |
| Company Name | Cefaly Technology SPRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us | |
| Phone | 1-844-475-7100 |
| info@cefaly.us |
Operating and Storage Conditions
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Humidity | Between 45 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05425018850273 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201895
FDA Product Code
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-25 |
| Device Publish Date | 2021-05-17 |
On-Brand Devices [Cefaly®]
| 05425018850129 | The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in |
| 05425018850259 | The Cefaly® Dual device is indicated for: - The acute treatment of migraine with or without aur |
| 05425018850242 | The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura |
| 05425018850150 | Kit 3 Electrodes Blue Gel for Cefaly II |
| 05425018850143 | Kit 3 electrodes for Cefaly II |
| 05425018850105 | Kit 3 electrodes Blue Gel for Cefaly I |
| 05425018850044 | Kit 3 electrodes for Cefaly I |
| 05425018850273 | Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indicat |
| 05425018850181 | Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes) |
| 05425018850174 | CEFALY Enhanced Electrode Kit .3 electrodes |
Trademark Results [Cefaly]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CEFALY 87924056 not registered Live/Pending |
CEFALY Technology 2018-05-16 |
 CEFALY 79053734 3647710 Live/Registered |
CEFALY Technology 2008-04-28 |
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