FDA UDI
In Commercial Distribution
🇺🇸 United States
SPEAK FOR LESS
DI: 05070003548507
·
Model: FP-A01
·
SPEAK FOR LESS LTD
Product Codes
1
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
Basic Information
- Brand Name
- SPEAK FOR LESS
- Primary DI
- 05070003548507
- Version / Model
- FP-A01
- Company Name
- SPEAK FOR LESS LTD
- Labeler DUNS
- 225195517
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-31
- Public Version
- 2
- Public Version Date
- 2025-06-09
- Public Version Status
- Update
- Public Device Record Key
- 7a0a6405-7450-45db-93c1-3783898ddac7
Device Description
An antistammering device intended to help individuals who stutter improve their level of fluency. The device modifies how users hear their own voice, supporting smoother and more controlled speech patterns by using Delayed Auditory Feedback (DAF) technology with a 70-millisecond time delay.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KTH | Device, Anti-Stammering | Ear, Nose, Throat | 874.5840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16343 | Antistammering device | A device designed to electronically generate a noise when activated or when it senses the user's speech. This device is intended to prevent the user from hearing the sound of his or her own voice and to minimize the user's involuntary hesitative or repetitive speech. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05070003548507 | GS1 | ||||
| Package | 15070003548504 | GS1 | 12 | In Commercial Distribution | ||
| Package | 25070003548501 | GS1 | 20 | In Commercial Distribution | ||
| Package | 35070003548508 | GS1 | 50 | In Commercial Distribution | ||
| Package | 45070003548505 | GS1 | 100 | In Commercial Distribution | ||
| Package | 55070003548502 | GS1 | 8 | In Commercial Distribution | ||
| Package | 65070003548509 | GS1 | 15 | In Commercial Distribution | ||
| Package | 75070003548506 | GS1 | 18 | In Commercial Distribution | ||
| Package | 85070003548503 | GS1 | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 888-773-2545
- [email protected]