Unitron
Vista T 610 Rd 13 (rechargeable)(ambersuede
4manufacturers in China registered for this device type
145catalogue 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 | Unitron Hearing, United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Premarket notification | Exempt |
| Record published | 2018-02-28 |
| Record revised | 2020-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 063-6003-01 | In distribution | |
| 050-6012-01 | In distribution | |
| 063-6011-01 | In distribution | |
| 050-5957-P7 | In distribution | |
| 063-6052-01 | In distribution | |
| 063-6010-01 | In distribution | |
| 050-5957-01 | In distribution | |
| 063-6007-01 | In distribution | |
| 050-5954-S5 | In distribution | |
| 050-5954-P6 | In distribution | |
| 050-5953-P6 | In distribution | |
| 063-6023-01 | In distribution | |
| 050-6010-S6 | In distribution | |
| 050-6013-P7 | In distribution | |
| 063-6053-01 | In distribution | |
| 063-6008-01 | In distribution | |
| 050-6020-P644 | In distribution | |
| 063-6030-01 | In distribution | |
| 050-5956-01 | In distribution | |
| 050-6010-P444 | In distribution | |
| 050-6014-S5 | In distribution | |
| 050-6014-P4 | In distribution | |
| 050-6019-P7 | In distribution | |
| 050-6010-0144 | In distribution | |
| 063-6002-01 | In distribution | |
| 050-6015-P744 | In distribution | |
| 050-6011-S3 | In distribution | |
| 050-6019-P4 | In distribution | |
| 050-6013-P644 | In distribution | |
| 063-6044-01 | In distribution | |
| 050-6010-S544 | In distribution | |
| 050-6018-P744 | In distribution | |
| 050-6012-Q9 | In distribution | |
| 063-6060-01 | In distribution | |
| 050-6021-S244 | In distribution | |
| 050-6012-P644 | In distribution | |
| 050-6018-S2 | In distribution | |
| 050-5957-S5 | In distribution | |
| 050-6013-Q9 | In distribution | |
| 063-6032-01 | In distribution | |
| 063-6014-01 | In distribution | |
| 063-6015-01 | In distribution | |
| 050-6013-P4 | In distribution | |
| 050-5954-P4 | In distribution | |
| 050-6020-P6 | In distribution | |
| 050-6013-S2 | In distribution | |
| 050-5955-S5 | In distribution | |
| 063-6035-01 | In distribution | |
| 050-6017-P644 | In distribution | |
| 050-6017-S2 | In distribution | |
| 050-6010-Q9 | In distribution | |
| 050-5955-P6 | In distribution | |
| 050-6017-P6 | In distribution | |
| 050-6014-0144 | In distribution | |
| 050-5957-P4 | In distribution | |
| 050-6011-P8 | In distribution | |
| 050-6013-P6 | In distribution | |
| 063-6041-01 | In distribution | |
| 063-6040-01 | In distribution | |
| 050-5956-P6 | In distribution | |
| 050-6012-P8 | In distribution | |
| 050-5955-01 | In distribution | |
| 050-5955-S2 | In distribution | |
| 063-6020-01 | In distribution | |
| 050-6014-P8 | In distribution | |
| 050-5956-P7 | In distribution | |
| 063-6009-01 | In distribution | |
| 050-6011-S2 | In distribution | |
| 050-6018-P4 | In distribution | |
| 050-6012-S2 | In distribution | |
| 050-6017-S244 | In distribution | |
| 063-6042-01 | In distribution | |
| 050-6011-P2 | In distribution | |
| 063-6049-01 | In distribution | |
| 050-5956-P4 | In distribution | |
| 050-6014-P644 | In distribution | |
| 063-6046-01 | In distribution | |
| 063-6048-01 | In distribution | |
| 050-5953-S2 | In distribution | |
| 063-6028-01 | In distribution | |
| 050-6012-P6 | In distribution | |
| 050-6021-P744 | In distribution | |
| 050-6013-S6 | In distribution | |
| 063-6059-01 | In distribution | |
| 050-6010-P2 | In distribution | |
| 050-6012-P4 | In distribution | |
| 050-5954-S2 | In distribution | |
| 050-6011-Q9 | In distribution | |
| 050-6014-01 | In distribution | |
| 050-6013-S544 | In distribution | |
| 063-6037-01 | In distribution | |
| 050-5957-S2 | In distribution | |
| 050-6012-P7 | In distribution | |
| 050-6011-P744 | In distribution | |
| 063-6058-01 | In distribution | |
| 050-6017-S5 | In distribution | |
| 063-6038-01 | In distribution | |
| 050-6017-01 | In distribution | |
| 050-5954-P7 | In distribution | |
| 050-6014-P7 | In distribution | |
| 063-6006-01 | In distribution | |
| 050-6019-S244 | In distribution | |
| 050-6012-S7 | In distribution | |
| 063-6047-01 | In distribution | |
| 063-6018-01 | In distribution | |
| 063-6029-01 | In distribution | |
| 063-6045-01 | In distribution | |
| 050-6010-S3 | In distribution | |
| 063-6031-01 | In distribution | |
| 063-6034-01 | In distribution | |
| 063-6033-01 | In distribution | |
| 063-6004-01 | In distribution | |
| 050-5956-S2 | In distribution | |
| 063-6021-01 | In distribution | |
| 050-6020-P4 | In distribution | |
| 050-6013-P8 | In distribution | |
| 050-6016-P744 | In distribution | |
| 063-6013-01 | In distribution | |
| 063-6001-01 | In distribution | |
| 050-5953-P4 | In distribution | |
| 050-6021-S544 | In distribution | |
| 050-6011-S244 | In distribution | |
| 050-6011-S6 | In distribution | |
| 050-6011-P644 | In distribution | |
| 050-5954-01 | In distribution | |
| 050-5957-P6 | In distribution | |
| 063-6043-01 | In distribution | |
| 050-5956-S5 | In distribution | |
| 050-6012-0144 | In distribution | |
| 063-6005-01 | In distribution | |
| 063-6039-01 | In distribution | |
| 063-6019-01 | In distribution | |
| 063-6012-01 | In distribution | |
| 050-6012-S244 | In distribution | |
| 050-6010-S2 | In distribution | |
| 050-5953-S5 | In distribution | |
| 063-6024-01 | In distribution | |
| 063-6016-01 | In distribution | |
| 050-6013-P744 | In distribution | |
| 050-5955-P4 | In distribution | |
| 063-6017-01 | In distribution | |
| 050-6010-S244 | In distribution | |
| 050-5953-P7 | In distribution | |
| 063-6022-01 | In distribution | |
| 050-5955-P7 | In distribution |
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 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130494 | 2013-05-07 |
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.