FDA product code QPY: Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
QPY is the FDA product code for stimulator, autonomic nerve, implanted for stroke rehabilitation. It is a Class III device, reviewed by the Physical Medicine panel. Devices under QPY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Stimulation of the vagus nerve
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation |
| Device class | Class III |
| Review panel | PM — Physical Medicine |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QPY devices
openFDA lists no recalls for product code QPY.
Frequently asked questions
What is FDA product code QPY?
QPY is the FDA product code for stimulator, autonomic nerve, implanted for stroke rehabilitation. It is a Class III device, reviewed by the Physical Medicine panel.
What device class is QPY?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QPY
- Run a recall and safety report across every QPY manufacturer
- Watch product code QPY 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.
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