FDA product code QRB: Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
QRB is the FDA product code for stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy. It is a Class III device, reviewed by the Neurology panel. Devices under QRB reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
To relieve pain in patients with diabetic neuropathy
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QRB devices
openFDA lists no recalls for product code QRB.
Frequently asked questions
What is FDA product code QRB?
QRB is the FDA product code for stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy. It is a Class III device, reviewed by the Neurology panel.
What device class is QRB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QRB
- Run a recall and safety report across every QRB manufacturer
- Watch product code QRB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.