Audifon
RITE Tinnitus
4manufacturers in China registered for this device type
277catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Audifon – Gmbh & Co.kg, Germany |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Manufacturer |
| 510(k) | K130514 |
| Record published | 2016-11-18 |
| Record revised | 2020-10-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-02-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| rega S | In distribution | |
| rega R | In distribution | |
| kami XS | In distribution | |
| kami XS | In distribution | |
| rega S | In distribution | |
| kami R | In distribution | |
| rega P | In distribution | |
| kami XS | In distribution | |
| sino XS | In distribution | |
| sino XS | In distribution | |
| kami P | In distribution | |
| rega S | In distribution | |
| kami XS | In distribution | |
| kami R | In distribution | |
| rega R | In distribution | |
| rega XS | In distribution | |
| kami XS | In distribution | |
| rega XS | In distribution | |
| kami XS | In distribution | |
| sino R | In distribution | |
| rega R | In distribution | |
| kami R | In distribution | |
| kami S | In distribution | |
| rega P | In distribution | |
| rega S | In distribution | |
| rega R | In distribution | |
| rega P | In distribution | |
| rega S | In distribution | |
| kami R | In distribution | |
| rega P | In distribution | |
| kami XS | In distribution | |
| rega XS | In distribution | |
| kami S | In distribution | |
| kami P | In distribution | |
| kami P | In distribution | |
| sino S | In distribution | |
| kami S | In distribution | |
| kami P | In distribution | |
| rega P | In distribution | |
| kami R | In distribution | |
| kami S | In distribution | |
| kami S | In distribution | |
| rega R | In distribution | |
| sino R | In distribution | |
| rega P | In distribution | |
| rega XS | In distribution | |
| kami P | In distribution | |
| kami S | In distribution | |
| kami R | In distribution | |
| rega R | In distribution | |
| rega P | In distribution | |
| kami P | In distribution | |
| kami S | In distribution | |
| rega P | In distribution | |
| sino S | In distribution | |
| rega XS | In distribution | |
| sino P | In distribution | |
| rega S | In distribution | |
| sino P | In distribution | |
| sino XS | In distribution | |
| rega S | In distribution | |
| rega R | In distribution | |
| sino R | In distribution | |
| kami R | In distribution | |
| sino P | In distribution | |
| rega XS | In distribution | |
| rega P | In distribution | |
| rega S | In distribution | |
| rega XS | In distribution | |
| kami R | In distribution | |
| kami XS | In distribution | |
| rega S | In distribution | |
| kami P | In distribution | |
| sino R | In distribution | |
| kami XS | In distribution | |
| rega R | In distribution | |
| sino P | In distribution | |
| kami S | In distribution | |
| sino S | In distribution | |
| rega XS | In distribution | |
| kami R | In distribution | |
| rega XS | In distribution | |
| rega R | In distribution | |
| kami S | In distribution | |
| vico S TRT | Withdrawn | |
| elia S TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| arriva M TRT | Withdrawn | |
| libra P TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| sueno T S | Withdrawn | |
| vico M TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| saga R TRT | Withdrawn | |
| switch TRT | Withdrawn | |
| arriva X TRT | Withdrawn | |
| sueno S | Withdrawn | |
| vico S+ TRT | Withdrawn | |
| elia XS TRT | Withdrawn | |
| vico XS TRT | Withdrawn | |
| switch TRT | Withdrawn | |
| switch 8 TRT | Withdrawn | |
| miro S+ TRT | Withdrawn | |
| arriva M TRT | Withdrawn | |
| elia S TRT | Withdrawn | |
| libra P TRT | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| vico P TRT | Withdrawn | |
| sueno R | Withdrawn | |
| arriva S TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| arriva X TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| elia S TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| arriva S TRT | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| arriva S TRT | Withdrawn | |
| miro R TRT | Withdrawn | |
| libra XS TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| sueno R | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| arriva M TRT | Withdrawn | |
| sueno R | Withdrawn | |
| libra P TRT | Withdrawn | |
| libra XS TRT | Withdrawn | |
| vico M TRT | Withdrawn | |
| arriva X TRT | Withdrawn | |
| saga R TRT | Withdrawn | |
| elia XS TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| sueno pro R | Withdrawn | |
| vico M TRT | Withdrawn | |
| miro P TRT | Withdrawn | |
| elia XS TRT | Withdrawn | |
| miro S+ TRT | Withdrawn | |
| elia XS TRT | Withdrawn | |
| vico S+ TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| arriva S+ TRT | Withdrawn | |
| arriva S+ TRT | Withdrawn | |
| vico S TRT | Withdrawn | |
| sueno S | Withdrawn | |
| sueno pro R | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| elia M TRT | Withdrawn | |
| vico M TRT | Withdrawn | |
| libra XS TRT | Withdrawn | |
| libra P TRT | Withdrawn | |
| saga R TRT | Withdrawn | |
| arriva M TRT | Withdrawn | |
| libra XS TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| arriva S+ TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| arriva X TRT | Withdrawn | |
| elis S TRT | Withdrawn | |
| vico P TRT | Withdrawn | |
| sueno S | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| miro S+ TRT | Withdrawn | |
| sueno S | Withdrawn | |
| saga P TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| sueno R | Withdrawn | |
| saga R TRT | Withdrawn | |
| arriva S+ TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| libra XS TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| saga R TRT | Withdrawn | |
| elia S TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| elia S TRT | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| libra P TRT | Withdrawn | |
| arriva S TRT | Withdrawn | |
| sueno S | Withdrawn | |
| switch 8 TRT | Withdrawn | |
| sueno T S | Withdrawn | |
| arriva S+ TRT | Withdrawn | |
| saga R TRT | Withdrawn | |
| libra XS TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| vico XS TRT | Withdrawn | |
| elia XS TRT | Withdrawn | |
| saga R TRT | Withdrawn | |
| miro XS TRT | Withdrawn | |
| elia XS TRT | Withdrawn | |
| miro R TRT | Withdrawn | |
| switch TRT | Withdrawn | |
| sueno T S | Withdrawn | |
| saga R TRT | Withdrawn | |
| sueno R | Withdrawn | |
| sueno S | Withdrawn | |
| miro P TRT | Withdrawn | |
| arriva S+ TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| vico S TRT | Withdrawn | |
| arriva S TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| elia XS TRT | Withdrawn | |
| vico P TRT | Withdrawn | |
| arriva X TRT | Withdrawn | |
| switch 8 TRT | Withdrawn | |
| arriva S TRT | Withdrawn | |
| elia M TRT | Withdrawn | |
| sueno T S | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| sueno T S | Withdrawn | |
| saga R TRT | Withdrawn | |
| vico XS TRT | Withdrawn | |
| prado M TRT | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| sueno pro R | Withdrawn | |
| miro P TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| libra P TRT | Withdrawn | |
| sueno R | Withdrawn | |
| elia S TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| miro XS TRT | Withdrawn | |
| libra R TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| saga S+ TRT | Withdrawn | |
| libra S+ TRT | Withdrawn | |
| elia S+ TRT | Withdrawn | |
| miro XS TRT | Withdrawn | |
| arriva M TRT | Withdrawn | |
| saga P TRT | Withdrawn | |
| vico S+ TRT | Withdrawn |
Showing 250 of 277 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
| Hansaton | Hansaton Akustik GmbH | 249 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091552 | 2009-08-12 |
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.