Identity
- Trade Name
- QuickTalker Freestyle Mini FDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Device Name
- The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to communicate with others. Individuals with Autism, physical or cognitive impairments that prevent clear speech and individuals who are non-verbal have all benefited from using a QuickTalker Freestyle speech device. FDA UDI
- Model / Reference
- 10000127 FDA UDI
- Description
- The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to communicate with others. Individuals with Autism, physical or cognitive impairments that prevent clear speech and individuals who are non-verbal have all benefited from using a QuickTalker Freestyle speech device. FDA UDI
Identifiers
- Catalog Number
- 10000127 FDA UDI
- Primary DI / UDI-DI
- 00850011150467 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Assistive speech generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 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
No
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: Assistive speech generator
QuickTalker Freestyle Mini by AbleNet Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- AbleNet Inc.
Sources (1)
- FDA UDI 66a3b87a-24f5-4966-8a46-9dde4bca9dcf 34 fields · synced May 30, 2026