FDA Device Establishments · JSON-LD · Markdown
FEI 3012213704 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3012213704 |
|---|---|
| Owner / Operator | Hearing Lab Technology, LLC (#10052054) |
| Address | 14301 FAA Blvd, Suite 105, Fort Worth, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | QUG |
| Regulation § (21 CFR) | 874.3305 |
| Proprietary names | Engage, Engage Rechargeable, Fio; Tala |
Source: openFDA. Public-domain (CC0).