Speax Digital Communication System for Home Use
SPEAX Digital Communication System for Home Use including Digital Communicator and Patches for Home Use
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Ataia Inc. |
|---|---|
| FDA product code | ILQ |
| Device type | System, Communication, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3710 |
| Premarket notification | Exempt |
| Record published | 2022-01-26 |
| Record revised | 2025-12-30 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -20 to 25 °C |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FGN-011 | Withdrawn |
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Showing 12 of 1,439. All products under System, Communication, 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.