FDA product code QLK: Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
QLK is the FDA product code for stimulator, neuromuscular, lower back muscles, totally implanted for pain relief. It is a Class III device, reviewed by the Neurology panel. Devices under QLK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QLK devices
openFDA lists no recalls for product code QLK.
Frequently asked questions
What is FDA product code QLK?
QLK is the FDA product code for stimulator, neuromuscular, lower back muscles, totally implanted for pain relief. It is a Class III device, reviewed by the Neurology panel.
What device class is QLK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLK
- Run a recall and safety report across every QLK manufacturer
- Watch product code QLK 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.