FDA device listing
SpineMED Express Cervical Decompression System,SpineMED Express Decompression System,SpineMED Professional Cervical…
FDA device listing 1907637459 · UNIVERSAL PAIN TECHNOLOGY CANADA INC.
Key facts
| Proprietary names | SpineMED Express Cervical Decompression System,SpineMED Express Decompression System,SpineMED Professional Cervical Decompression System,SpineMED Professional Decompression System,SpineMED Ultra Cervical Decompression System,SpineMED Ultra Decompression System |
|---|---|
| Owner/operator | UNIVERSAL PAIN TECHNOLOGY CANADA INC. |
| Owner/operator number | 9046648 |
| Premarket submissions | K051013 |
| Product codes | ITH |
| Device names | ITH - Equipment, Traction, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5900 |
| Review panels | Physical Medicine |
| Registered establishments | UNIVERSAL PAIN TECHNOLOGY CANADA INC. |
| Establishment registrations | 3002654235 |
| FEI numbers | 3002654235 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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