TruTone Plus® Electrolarynx
TruTone Plus® Electrolarynx version 2
1manufacturer
7catalogue numbers in this listing
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
Record
| Listed by | Griffin Laboratories |
|---|---|
| FDA product code | ESE |
| Device type | Larynx, Artificial (Battery-Powered) |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3375 |
| Premarket notification | Exempt |
| Record published | 2019-10-23 |
| Record revised | 2023-01-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K120 | In distribution | |
| KD120 | In distribution | |
| K120 | In distribution | |
| KD120 | In distribution | |
| K360-2 | In distribution | |
| K121 | In distribution | |
| 7444 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Parlez Electrolarynx | Elogio Speech Technologies LLC | 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.