Identity
- Trade Name
- ISSA™ mini FDA UDI
- Generic Name
- Basic electric toothbrush FDA UDI
- Device Name
- 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+. FDA UDI
- Model / Reference
- SUMMER SKY FDA UDI
- Description
- 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+. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350071074954 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™ mini 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 266eeb6a-ba69-44ed-9e2a-1b0e42b3a1f3 33 fields · synced Jun 1, 2026