Duns Number:352394143
Device Description: ISSA™ mini is a powered toothbrush that helps parents to monitor that their children are b ISSA™ mini is a powered toothbrush that helps parents to monitor that their children are brushing their teeth twice a day. Featuring parental controls, the sad face ('Glum') will appear if teeth haven't been brushed in over 12 hours. The happy face ('Glee') will appear when teeth have been brushed for 2 minutes. With 2 speed settings, you can ensure your child is cleaning their teeth effectively. The ISSA™ mini is suitable for children ages 5+.
Catalog Number
-
Brand Name
ISSA™ mini
Version/Model Number
ENCHANTED VIOLET
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
-
Product Code
JEQ
Product Code Name
Toothbrush, Powered
Public Device Record Key
d98ce8bd-8965-40ea-b174-f30a6ed7c025
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |