Duns Number:675938472
Device Description: Mindgear is cranial electrotherapy device and it is indicated for use CES for the treatmen Mindgear is cranial electrotherapy device and it is indicated for use CES for the treatment of insomnia and anxiety. Key Features: 510(K) cleared device, Portable and user-friendly device, Used for the treatment of insomnia and anxiety.
Catalog Number
-
Brand Name
Johari Digital Healthcare Ltd.
Version/Model Number
MINDGEAR
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090052
Product Code
JXK
Product Code Name
Cranial Electrotherapy Stimulator To Treat Depression
Public Device Record Key
f9411334-921e-4b2e-a073-4f848d246d42
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 12, 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. | 41 |
| 3 | A medical device with high risk that requires premarket approval | 1 |