DEVICE: Cefaly® (05425018850129)
Device Identifier (DI) Information
Cefaly®
10205
In Commercial Distribution
Cefaly Technology SPRL
10205
In Commercial Distribution
Cefaly Technology SPRL
Set Cefaly® :
- Instruction manual
- Cefaly® device
- Cefaly® electrode
- Storage box
- Power adapter + cable
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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 [?] |
---|---|
K160237 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Humidity: between 45 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between 23 and 95 Degrees Fahrenheit |
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
f34119a1-f8a9-4767-a025-87d06a96562d
March 11, 2019
4
September 17, 2016
March 11, 2019
4
September 17, 2016
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
[?]
(203) 309-5670
info@cefaly.us
info@cefaly.us