FDA Device Establishments · JSON-LD · Markdown
FEI 3010391227 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3010391227 |
|---|---|
| Owner / Operator | W-Medical (#10044683) |
| Address | 4F, 402, Byeollae 3-ro, Namyangju-si Gyeonggi, 12097, KR |
| Mandatory US Agent | CL MEDIX INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ISA |
| Regulation § (21 CFR) | 890.5660 |
| Proprietary names | MiracleWave Plus; The Miracle wave HP50; The Miracle wave Handywave; The Miracle wave Shockwave F1 |
Source: openFDA. Public-domain (CC0).