Duns Number:762450752
Device Description: The Cefaly® Dual device is indicated for:- The acute treatment of migraine with or without The Cefaly® Dual device is indicated for:- The acute treatment of migraine with or without aura in patients 18 years of age or older.- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Catalog Number
10505
Brand Name
Cefaly®
Version/Model Number
Dual
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173006
Product Code
PCC
Product Code Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Public Device Record Key
3d1cf57f-c862-431e-a794-8129db044471
Public Version Date
March 11, 2019
Public Version Number
4
DI Record Publish Date
November 29, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |