DEVICE: Cefaly® (05425018850280)
Device Identifier (DI) Information
Cefaly®
CEFALY Enhanced
In Commercial Distribution
10701
Cefaly Technology SPRL
CEFALY Enhanced
In Commercial Distribution
10701
Cefaly Technology SPRL
CEFALY Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use.
CEFALY Enhanced is indicated to be used for:
Acute treatment of migraine with or without aura in patients 18 years of age or older.
Preventative treatment of migraine in patients 18 years of age or older.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60682 | Craniofacial analgesia electrical stimulator |
A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K212071 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 23 and 95 Degrees Fahrenheit |
Storage Environment Humidity: between 45 and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Temperature: between 50 and 95 Degrees Fahrenheit |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ead85ab2-c422-4bc5-9c2f-0271daa14a50
December 30, 2022
1
December 22, 2022
December 30, 2022
1
December 22, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-844-475-7100
info@cefaly.us
info@cefaly.us