Identity
- Trade Name
- ISSA™ FDA UDI
- Generic Name
- Basic electric toothbrush FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- COOL BLACK FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350071073322 FDA UDI
- FDA Product Code
- JEQ FDA UDI
- GMDN Term
- Basic electric toothbrush FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6865 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic electric toothbrush
Issa™ by Foreo Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foreo Inc
Sources (1)
- FDA UDI 79581618-6a5f-43a0-9d4b-bb297fc233e6 33 fields · synced Jun 6, 2026