Product code
QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
FDA product code · Class III · Neurology
Key facts
| Product code | QRB |
|---|---|
| Device | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy |
| Device class | Class III |
| Review panel | Neurology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | To relieve pain in patients with diabetic neuropathy |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database