Data / Medical devices / Hong Kong / Shokz Health Global Limited
Shokz Health Global Limited: FDA-registered device maker in Kowloon, Hong Kong, 1 510(k) clearance
Shokz Health Global Limited is registered with the FDA (registration 3049809193) in Kowloon, Hong Kong. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 19, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3049809193
- Address
- Room 708, 7TH Floor, Hang Seng Castle Peak Road Building 339 Castle Peak Road, Cheung Sha Wan, Kowloon, Hong Kong, 000000
- Owner or operator
- Shokz Health Global Limited (10096337)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- September 11, 2026
- Registered through
- 2027
- Brand names listed
- Bone conduction hearing aid
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Bone Conduction | LXB | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 19, 2026 | K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | LXB | Substantially Equivalent | Shokz Health Global Limited | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.