Duns Number:762450752
Device Description: Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device In 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.
Catalog Number
10601
Brand Name
Cefaly®
Version/Model Number
CEFALY DUAL Enhanced
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201895
Product Code
PCC
Product Code Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Public Device Record Key
ff92c926-fe58-4f4b-bf24-a57b7e3df6a4
Public Version Date
May 25, 2021
Public Version Number
1
DI Record Publish Date
May 17, 2021
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 |