ISSA™ - The FOREO ISSA™ is the world's first electric - Foreo AB

Duns Number:352394143

Device Description: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA chan The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels high-intensity pulsation through its unique brush head to clean teeth gently and effectively, utilizing silicone's natural friction properties to remove plaque while offering a comfortable gum massage for a cleaner, healthier mouth. Its ultra-hygienic, soft silicone bristles are gentle on tooth enamel and gums, while its sleek, ergonomic design offers 3D flexibility, reaching every crevice in the mouth. Easy to clean and sterilize, ISSA is quick-drying, nonporous and resistant to bacteria buildup, making it far more hygienic than nylon-bristled toothbrushes. Easy to use with a single-button interface and eight adjustable speeds, ISSA reminds you to switch quadrants every 30 seconds and signals when your two-minute brushing routine is over. The 100% waterproof device is travel friendly, requiring no charging dock—a single full charge lasts for 365 uses. The brush head only needs replacement once per year.

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More Product Details

Catalog Number

-

Brand Name

ISSA™

Version/Model Number

COBALT BLUE

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

ade80d85-70c5-44a9-81aa-5e249f533b41

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