ISSA™ mini - ISSA™ mini is a powered toothbrush that helps - Foreo AB

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+.

Want to know more about this Product? Request more information now!


More Product Details

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

Product Characteristics

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 Details

Product Code

JEQ

Product Code Name

Toothbrush, Powered

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FOREO AB" Characteristics
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