AccessGUDID - DEVICE: SPEAK FOR LESS (05070003548507)

GUDID

Device Identifier (DI) Information

Brand Name: SPEAK FOR LESS
Version or Model: FP-A01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPEAK FOR LESS LTD

Primary DI Number: 05070003548507
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 225195517 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTH	Device, Anti-Stammering

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a0a6405-7450-45db-93c1-3783898ddac7
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: January 31, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
15070003548504	12	05070003548507	In Commercial Distribution
25070003548501	20	05070003548507	In Commercial Distribution
35070003548508	50	05070003548507	In Commercial Distribution
45070003548505	100	05070003548507	In Commercial Distribution
55070003548502	8	05070003548507	In Commercial Distribution
65070003548509	15	05070003548507	In Commercial Distribution
75070003548506	18	05070003548507	In Commercial Distribution
85070003548503	4	05070003548507	In Commercial Distribution