FDA Device Establishments · JSON-LD · Markdown
FEI 3015972815 · Manufacture Medical Device · Status: Active
| FEI Number | 3015972815 |
|---|---|
| Owner / Operator | GH Innotek Co., Ltd. (#10084379) |
| Address | 2F, Room B2, 68, Busandaehak-ro 50beon-gil, Geumjeong-gu Busan, 46285, KR |
| Mandatory US Agent | J.S. CHEM INTERNATIONAL CO. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ION |
| Regulation § (21 CFR) | 890.5370 |
| Proprietary names | Bigbreathe Double Action IMT/PEP; Bigbreathe S-IMT; Bigbreathe BreST Mask; Bigbreathe IMT; Bigbreathe Double Action V-PEP/IMT; IMT/PEP 100; Bigbreathe Double Action O-PEP/IMT |
Source: openFDA. Public-domain (CC0).