FDA Device Establishments · JSON-LD · Markdown
FEI 3015259856 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3015259856 |
|---|---|
| Owner / Operator | Helius Medical, Inc (#10059664) |
| Address | 642 Newtown Yardley Rd., Suite 100, Newtown, PA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QCF |
| Regulation § (21 CFR) | 882.5889 |
| Proprietary names | Portable Neuromodulation Stimulator (PoNS) |
Source: openFDA. Public-domain (CC0).