FDA product code LOA: Device, Testicular Hypothermia
LOA is the FDA product code for device, testicular hypothermia. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under LOA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Device, Testicular Hypothermia |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LOA devices
openFDA lists no recalls for product code LOA.
Frequently asked questions
What is FDA product code LOA?
LOA is the FDA product code for device, testicular hypothermia. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is LOA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LOA
- Run a recall and safety report across every LOA manufacturer
- Watch product code LOA 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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