FDA UDI
In Commercial Distribution
🇺🇸 United States
QuickTalker Freestyle
DI: 00850011150481
·
Model: 10000129
·
Ablenet, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- QuickTalker Freestyle
- Primary DI
- 00850011150481
- Version / Model
- 10000129
- Catalog Number
- 10000129
- Company Name
- Ablenet, Inc.
- Labeler DUNS
- 791664543
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-18
- Public Version
- 1
- Public Version Date
- 2025-06-26
- Public Version Status
- New
- Public Device Record Key
- 7879e0ab-e10b-45a6-bd3b-a418ed8c4aba
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILQ | System, Communication, Powered | Physical Medicine | 890.3710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65767 | Assistive speech generator | An electrically-powered device designed to facilitate communication by a patient with a disability and/or cognitive impairment by providing buttons with images that when pressed produce audible pre-recorded words or phrases associated with the images. It is a unit with a set of buttons/keyboard displaying symbols/pictures, a recording function, and a speaker. It is intended for use both in the home and healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011150481 | GS1 |