FDA Device Establishments · JSON-LD · Markdown
FEI 3011853771 · Manufacture Medical Device · Status: Active
| FEI Number | 3011853771 |
|---|---|
| Owner / Operator | Focal Healthcare Inc. (#10051236) |
| Address | 10 Morrow Ave., Unit 101, Toronto Ontario, M6R2J1, CA |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KMN |
| Regulation § (21 CFR) | 880.6140 |
| Proprietary names | Fusion Stepper |
Source: openFDA. Public-domain (CC0).