ISSA™

GUDID 07350071073315

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.

Foreo AB

Basic electric toothbrush

• Primary Device ID: 07350071073315
• NIH Device Record Key: 75f658ba-ad4a-4169-8b88-285c354a48da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISSA™
• Version Model Number: COBALT BLUE
• Company DUNS: 352394143
• Company Name: Foreo AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350071073315 [Primary]

FDA Product Code

• JEQ: Toothbrush, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-03
• Device Publish Date: 2022-05-26

On-Brand Devices [ISSA™ ]

• 07350071074916: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels
• 07350071074909: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels
• 07350071074886: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels
• 07350071073322: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels
• 07350071073315: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels
• 07350071073308: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels
• 07350071073292: The FOREO ISSA™ is the world's first electric toothbrush with silicone bristles, ISSA channels