Parlez Electrolarynx

Handheld battery-powered artificial larynx intended to assist speech production in individuals who have undergone laryngectomy or otherwise require an external sound source for verbal…

Registry build 21.09.26

Handheld battery-powered artificial larynx intended to assist speech production in individuals who have undergone laryngectomy or otherwise require an external sound source for verbal communication. The device generates mechanical vibration that is transmitted through the neck tissues or optional oral adapter to facilitate intelligible speech through articulation.

1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Tianjin.

Chinese manufacturers registered for FDA product code ESE
Manufacturer City Province Registered as Device types
Tianjin Tairuibosi Medical Appliance Co., Ltd. Tianjin Tianjin Private-label distributor 30

Record

Regulatory record for Parlez Electrolarynx
Listed by Elogio Speech Technologies LLC, United States
FDA product code ESE
Device type Larynx, Artificial (Battery-Powered)
Device class Class 1
Regulation 21 CFR 874.3375
Establishment Manufacturer
Premarket notification Exempt
Record published 2026-06-09

Specifications

Specifications
MRI safety MR Unsafe
Over the counter Yes
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Parlez Electrolarynx
Catalogue number Size Status
Parlez XL In distribution
Parlez In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
TruTone Plus® Electrolarynx Griffin Laboratories 7
SolaTone Plus™ Electrolarynx Griffin Laboratories 6
TruTone® Electrolarynx Griffin Laboratories 6
TruTone Emote® Electrolarynx Griffin Laboratories 6
SolaTone® Electrolarynx Griffin Laboratories 6
Romet Fountain Head Marketing Inc 5
Blom-Singer Ent Solutions LLC 4
TeliTalk™ Electrolarynx Griffin Laboratories 4
SolaTone Lite® Electrolarynx Griffin Laboratories 2
Liberty® Electrolarynx Griffin Laboratories 1
Provox SolaTone Plus Atos Medical AB 1
Provox TruTone Plus Atos Medical AB 1

Showing 12 of 15. All products under Larynx, Artificial (Battery-Powered)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer