Duns Number:675938472
Device Description: STIM TENS is cranial electrotherapy device and it provides powerful, predictable, proven s STIM TENS is cranial electrotherapy device and it provides powerful, predictable, proven stress relieving experience, Treatments for Insomnia. Key Features: 510(K) cleared device, Portable and user-friendly device, Used for Treatments for Anxiety and Insomnia.
Catalog Number
-
Brand Name
Johari Digital Healthcare Ltd.
Version/Model Number
STIM TENS
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090052
Product Code
QJQ
Product Code Name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Public Device Record Key
11b54aca-c2f6-4820-9f6b-bdfc1d0ba1fb
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
October 30, 2020
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 |