FDA Device Establishments · JSON-LD · Markdown
FEI 3049809193 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3049809193 |
|---|---|
| Owner / Operator | Shokz Health Global Limited (#10096337) |
| Address | ROOM 708, 7TH FLOOR, HANG SENG CASTLE PEAK ROAD BUILDING, 339 CASTLE PEAK ROAD, CHEUNG SHA WAN, KOWLOON, 000000, HK |
| Registration expiry | 2027 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LXB |
| Regulation § (21 CFR) | 874.3302 |
| Proprietary names | Bone conduction hearing aid |
Source: openFDA. Public-domain (CC0).