FDA product code QOW: Ventilatory Assistance Helmet
QOW is the FDA product code for ventilatory assistance helmet. It is a Not classified device, reviewed by the Anesthesiology panel. Devices under QOW reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Patient interface for delivery of positive pressure to assist patient's breathing during declared public health emergency. Can be used with continuous and non-continuous ventilators, wall gas source, oxygen source, humidified gases.
Classification
| Field | Value |
|---|---|
| Device name | Ventilatory Assistance Helmet |
| Device class | Not classified |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOW devices
openFDA lists no recalls for product code QOW.
Frequently asked questions
What is FDA product code QOW?
QOW is the FDA product code for ventilatory assistance helmet. It is a Not classified device, reviewed by the Anesthesiology panel.
What device class is QOW?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOW
- Run a recall and safety report across every QOW manufacturer
- Watch product code QOW 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.