Servox Digital XL
The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgical removal of the larynx, the opportunity to quickly regain the ability to…
The SERVOX® digital XL speech aid offers patients, who have lost their voice due to injury, illness or surgical removal of the larynx, the opportunity to quickly regain the ability to communicate. The SERVOX® digital XL can also be used by patients who are temporarily voiceless due to a tracheotomy, who have to protect their vocal folds due to illness or who are connected to a respirator.
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 | Servona GmbH |
|---|---|
| FDA product code | ESE |
| Device type | Larynx, Artificial (Battery-Powered) |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3375 |
| Premarket notification | Exempt |
| Record published | 2021-02-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37575 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
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| 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 |
| Parlez Electrolarynx | Elogio Speech Technologies LLC | 2 |
| Liberty® Electrolarynx | Griffin Laboratories | 1 |
| Provox SolaTone 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.