SPEAK FOR LESS

Primary DI
05070003548507
Brand
SPEAK FOR LESS
Company
SPEAK FOR LESS LTD
Model
FP-A01
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.
Published
2025-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTHDevice, Anti-Stammering

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTHDevice, Anti-StammeringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15070003548504PackageGS112In Commercial Distribution
25070003548501PackageGS120In Commercial Distribution
35070003548508PackageGS150In Commercial Distribution
45070003548505PackageGS1100In Commercial Distribution
55070003548502PackageGS18In Commercial Distribution
65070003548509PackageGS115In Commercial Distribution
75070003548506PackageGS118In Commercial Distribution
85070003548503PackageGS14In Commercial Distribution
05070003548507PrimaryGS10
05070003548514Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1507000354850415070003548504
2507000354850125070003548501
3507000354850835070003548508
4507000354850545070003548505
5507000354850255070003548502
6507000354850965070003548509
7507000354850675070003548506
8507000354850385070003548503
05070003548507050700035485075070003548507
05070003548514050700035485145070003548514

GMDN Terms#

Term, Definition table
TermDefinition
Antistammering deviceA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888-773-2545info@speakforless.com

Regulatory Flags#

DUNS number
225195517
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true