510(k) K261256— Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

Substantially Equivalent

Shenzhen Magnet Technology Co., Ltd.

Clearance details

Applicant: Shenzhen Magnet Technology Co., Ltd.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 2026-04-16
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.