FDA product code QLV: Field Generator Positioning Device
QLV is the FDA product code for field generator positioning device. It is a Class I device, regulated under 21 CFR 882.4565 and reviewed by the Ear, Nose and Throat panel. Devices under QLV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.
Classification
| Field | Value |
|---|---|
| Device name | Field Generator Positioning Device |
| Device class | Class I |
| Regulation | 21 CFR 882.4565 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for QLV devices
openFDA lists no recalls for product code QLV.
Frequently asked questions
What is FDA product code QLV?
QLV is the FDA product code for field generator positioning device. It is a Class I device, regulated under 21 CFR 882.4565 and reviewed by the Ear, Nose and Throat panel.
What device class is QLV?
Class I, regulation 21 CFR 882.4565. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QLV
- Run a recall and safety report across every QLV manufacturer
- Watch product code QLV 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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