SPEAK FOR LESS

GUDID 05070003548507

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.

SPEAK FOR LESS LTD

Antistammering device
Primary Device ID05070003548507
NIH Device Record Key7a0a6405-7450-45db-93c1-3783898ddac7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPEAK FOR LESS
Version Model NumberFP-A01
Company DUNS225195517
Company NameSPEAK FOR LESS LTD
Device Count2
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com
Phone+1 888-773-2545
Emailinfo@speakforless.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105070003548507 [Primary]
GS105070003548514 [Unit of Use]
GS115070003548504 [Package]
Package: [12 Units]
In Commercial Distribution
GS125070003548501 [Package]
Package: [20 Units]
In Commercial Distribution
GS135070003548508 [Package]
Package: [50 Units]
In Commercial Distribution
GS145070003548505 [Package]
Package: [100 Units]
In Commercial Distribution
GS155070003548502 [Package]
Package: [8 Units]
In Commercial Distribution
GS165070003548509 [Package]
Package: [15 Units]
In Commercial Distribution
GS175070003548506 [Package]
Package: [18 Units]
In Commercial Distribution
GS185070003548503 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Product Code

KTHDevice, Anti-Stammering

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-10
Device Publish Date2025-01-31
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.