Oticon
Xceed Play 1, BTE UP 675 2.4G 120 C094 TAR
4manufacturers in China registered for this device type
353catalogue 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 | Oticon A/S, Denmark |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-20 |
| Record revised | 2025-03-05 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2028-03-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 182597 | In distribution | |
| 182749 | In distribution | |
| 150863 | In distribution | |
| 221874 | In distribution | |
| 222564 | In distribution | |
| 178940 | In distribution | |
| 221892 | In distribution | |
| 222009 | In distribution | |
| 178957 | In distribution | |
| 150722 | In distribution | |
| 182748 | In distribution | |
| 182600 | In distribution | |
| 175662 | In distribution | |
| 178948 | In distribution | |
| 182595 | In distribution | |
| 221968 | In distribution | |
| 150296 | In distribution | |
| 182754 | In distribution | |
| 191971 | In distribution | |
| 191979 | In distribution | |
| 190476 | In distribution | |
| 175670 | In distribution | |
| 209219 | In distribution | |
| 222010 | In distribution | |
| 222006 | In distribution | |
| 175661 | In distribution | |
| 209282 | In distribution | |
| 202024 | In distribution | |
| 204448 | In distribution | |
| 150223 | In distribution | |
| 184286 | In distribution | |
| 181627 | In distribution | |
| 150931 | In distribution | |
| 221880 | In distribution | |
| 194901 | In distribution | |
| 191960 | In distribution | |
| 178963 | In distribution | |
| 193881 | In distribution | |
| 191896 | In distribution | |
| 175659 | In distribution | |
| 191965 | In distribution | |
| 178943 | In distribution | |
| 221951 | In distribution | |
| 221893 | In distribution | |
| 150432 | In distribution | |
| 208858 | In distribution | |
| 214207 | In distribution | |
| 209236 | In distribution | |
| 146339 | In distribution | |
| 191933 | In distribution | |
| 221957 | In distribution | |
| 146355 | In distribution | |
| 190492 | In distribution | |
| 182737 | In distribution | |
| 199519 | In distribution | |
| 221948 | In distribution | |
| 182590 | In distribution | |
| 208860 | In distribution | |
| 182602 | In distribution | |
| 209274 | In distribution | |
| 191909 | In distribution | |
| 182587 | In distribution | |
| 150429 | In distribution | |
| 187778 | In distribution | |
| 222002 | In distribution | |
| 193198 | In distribution | |
| 190046 | In distribution | |
| 221961 | In distribution | |
| 200294 | In distribution | |
| 182751 | In distribution | |
| 190409 | In distribution | |
| 191975 | In distribution | |
| 150451 | In distribution | |
| 190483 | In distribution | |
| 146341 | In distribution | |
| 191904 | In distribution | |
| 222005 | In distribution | |
| 221881 | In distribution | |
| 221887 | In distribution | |
| 221888 | In distribution | |
| 191902 | In distribution | |
| 209271 | In distribution | |
| 199529 | In distribution | |
| 150219 | In distribution | |
| 190490 | In distribution | |
| 221868 | In distribution | |
| 178962 | In distribution | |
| 221962 | In distribution | |
| 191956 | In distribution | |
| 184280 | In distribution | |
| 182722 | In distribution | |
| 182583 | In distribution | |
| 178966 | In distribution | |
| 221950 | In distribution | |
| 150724 | In distribution | |
| 209281 | In distribution | |
| 150094 | In distribution | |
| 191968 | In distribution | |
| 191913 | In distribution | |
| 187780 | In distribution | |
| 191942 | In distribution | |
| 150243 | In distribution | |
| 153886 | In distribution | |
| 175658 | In distribution | |
| 221966 | In distribution | |
| 191924 | In distribution | |
| 178961 | In distribution | |
| 182752 | In distribution | |
| 191951 | In distribution | |
| 182738 | In distribution | |
| 202026 | In distribution | |
| 214643 | In distribution | |
| 194900 | In distribution | |
| 190468 | In distribution | |
| 175657 | In distribution | |
| 150928 | In distribution | |
| 221953 | In distribution | |
| 182585 | In distribution | |
| 182728 | In distribution | |
| 196707 | In distribution | |
| 182730 | In distribution | |
| 193730 | In distribution | |
| 182735 | In distribution | |
| 191949 | In distribution | |
| 209216 | In distribution | |
| 181781 | In distribution | |
| 149601 | In distribution | |
| 219645 | In distribution | |
| 204451 | In distribution | |
| 190402 | In distribution | |
| 182601 | In distribution | |
| 191465 | In distribution | |
| 204675 | In distribution | |
| 178946 | In distribution | |
| 184277 | In distribution | |
| 191918 | In distribution | |
| 221891 | In distribution | |
| 190410 | In distribution | |
| 178965 | In distribution | |
| 150089 | In distribution | |
| 181629 | In distribution | |
| 222019 | In distribution | |
| 182617 | In distribution | |
| 146348 | In distribution | |
| 150433 | In distribution | |
| 182758 | In distribution | |
| 196704 | In distribution | |
| 182578 | In distribution | |
| 175668 | In distribution | |
| 150098 | In distribution | |
| 208086 | In distribution | |
| 221958 | In distribution | |
| 146352 | In distribution | |
| 182603 | In distribution | |
| 190462 | In distribution | |
| 208854 | In distribution | |
| 191948 | In distribution | |
| 222004 | In distribution | |
| 184281 | In distribution | |
| 190489 | In distribution | |
| 151073 | In distribution | |
| 204670 | In distribution | |
| 150866 | In distribution | |
| 149514 | In distribution | |
| 214641 | In distribution | |
| 182573 | In distribution | |
| 190485 | In distribution | |
| 182612 | In distribution | |
| 178945 | In distribution | |
| 190050 | In distribution | |
| 191970 | In distribution | |
| 221967 | In distribution | |
| 182575 | In distribution | |
| 191945 | In distribution | |
| 214642 | In distribution | |
| 191893 | In distribution | |
| 191940 | In distribution | |
| 182764 | In distribution | |
| 178972 | In distribution | |
| 221872 | In distribution | |
| 182579 | In distribution | |
| 204449 | In distribution | |
| 226568 | In distribution | |
| 191927 | In distribution | |
| 146351 | In distribution | |
| 150244 | In distribution | |
| 191895 | In distribution | |
| 178959 | In distribution | |
| 146363 | In distribution | |
| 209237 | In distribution | |
| 191943 | In distribution | |
| 191958 | In distribution | |
| 222008 | In distribution | |
| 221955 | In distribution | |
| 181797 | In distribution | |
| 150218 | In distribution | |
| 182604 | In distribution | |
| 191964 | In distribution | |
| 182570 | In distribution | |
| 182743 | In distribution | |
| 190479 | In distribution | |
| 191959 | In distribution | |
| 221869 | In distribution | |
| 182740 | In distribution | |
| 209224 | In distribution | |
| 190484 | In distribution | |
| 185943 | In distribution | |
| 190461 | In distribution | |
| 208857 | In distribution | |
| 191894 | In distribution | |
| 182753 | In distribution | |
| 182567 | In distribution | |
| 222015 | In distribution | |
| 150427 | In distribution | |
| 191452 | In distribution | |
| 150238 | In distribution | |
| 184287 | In distribution | |
| 150927 | In distribution | |
| 182761 | In distribution | |
| 150303 | In distribution | |
| 222017 | In distribution | |
| 149517 | In distribution | |
| 153767 | In distribution | |
| 190062 | In distribution | |
| 149602 | In distribution | |
| 149515 | In distribution | |
| 182725 | In distribution | |
| 190473 | In distribution | |
| 150305 | In distribution | |
| 182727 | In distribution | |
| 150295 | In distribution | |
| 209222 | In distribution | |
| 150302 | In distribution | |
| 221875 | In distribution | |
| 221965 | In distribution | |
| 191917 | In distribution | |
| 191926 | In distribution | |
| 204452 | In distribution | |
| 190047 | In distribution | |
| 183832 | In distribution | |
| 150086 | In distribution | |
| 150864 | In distribution | |
| 191912 | In distribution | |
| 209232 | In distribution | |
| 150087 | In distribution | |
| 209268 | In distribution | |
| 178956 | In distribution | |
| 224630 | In distribution | |
| 178960 | In distribution | |
| 224628 | In distribution |
Showing 250 of 300 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 |
| 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 |
| Hansaton | Hansaton Akustik GmbH | 249 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133308 | 2014-03-18 |
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.