FDA product code OVX: Water Immersion Labor Pool

OVX is the FDA product code for water immersion labor pool. It is a Not classified device, reviewed by the Obstetrics and Gynecology panel. Devices under OVX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

Partial water immersion during labor in hospitals, birth centers and home.

Classification

FieldValue
Device nameWater Immersion Labor Pool
Device classNot classified
Review panelOB — Obstetrics and Gynecology
Medical specialtyUnknown
Premarket route510(k) exempt

Recalls for OVX devices

openFDA lists no recalls for product code OVX.

Frequently asked questions

What is FDA product code OVX?

OVX is the FDA product code for water immersion labor pool. It is a Not classified device, reviewed by the Obstetrics and Gynecology panel.

What device class is OVX?

Not classified. Typical premarket route: 510(k) exempt.

Next steps

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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