Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
FDA 510(k) clearance K261256 · decided 2026-06-11
Clearance details
- K-number
- K261256
- Device name
- Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- Applicant
- Shenzhen Magnet Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-04-16
- Decision date
- 2026-06-11
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.