510(k) K253431
- Device
- Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- Applicant
- Shokz Health Global Limited
- 510(k) number
- K253431
- Product code
- LXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-19
- Date received
- 2025-10-01
- Regulation
- 874.3302
- Classification name
- Hearing Aid, Bone Conduction
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Guihong Dai
- Address
- Rm. 708, 7th Floor, Hang Seng Castle Peak Rd. Bldg. 339 Castle Peak Rd., Cheung Sha Wan Kowloon HK
FDA Registration Numbers#
- 3007689689
- 3007743836
- 3005216725
- 3009092818
- 3010097171
- 9616024
- 3012593436
- 3009307953
- 3006405073
- 3005150478
- 3018094310
- 9710014
- 3014990990
- 3003477135
- 3043654373
- 3034209804
- 3020283264
- 3027588012
- 1045254
- 3014579188
- 3010376846
- 3005900820
- 8031010
- 9612468
- 3007275459
- 3003847101
- 3007367732
- 3033905868
- 3009632672
- 3005820796
- 3013177549
- 9613646
Source Documents#
Other 510(k) Records For Product Code LXB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254296 | Ossiclear (Ossiclear System) | Sounduct | 2026-07-22 |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | 2025-05-29 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | 2021-09-29 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | 2021-02-23 |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016-09-29 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016-06-16 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 |