FDA device listing
Orthosis, Cranial, Laser Scan
FDA device listing 1612679403 · Vorum Research Corporation (dba Qwadra Vancouver)
Key facts
| Owner/operator | Vorum Research Corporation (dba Qwadra Vancouver) |
|---|---|
| Owner/operator number | 10054597 |
| Product codes | OAN |
| Device names | OAN - Orthosis, Cranial, Laser Scan |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5970 |
| Review panels | Neurology |
| Registered establishments | VORUM RESEARCH CORPORATION |
| Establishment registrations | 1000239400 |
| FEI numbers | 1000239400 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database