DEVICE: Cefaly® (05425018850280)

Device Identifier (DI) Information

Cefaly®
CEFALY Enhanced
In Commercial Distribution
10701
Cefaly Technology SPRL
05425018850280
GS1

1
762450752 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
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.
Active false
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FDA Product Code

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Product Code Product Code Name
PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K212071 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ead85ab2-c422-4bc5-9c2f-0271daa14a50
December 30, 2022
1
December 22, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
Yes
No
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Customer Contact

[?]
1-844-475-7100
info@cefaly.us
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