FDA product code NBN: Generator, Shock-Wave, For Pain Relief
NBN is the FDA product code for generator, shock-wave, for pain relief. It is a Class III device, reviewed by the Orthopedic panel. Devices under NBN reach the market by PMA; FDA lists no cleared 510(k)s for it. 7 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Generator, Shock-Wave, For Pain Relief |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NBN devices
openFDA lists no recalls for product code NBN.
Frequently asked questions
What is FDA product code NBN?
NBN is the FDA product code for generator, shock-wave, for pain relief. It is a Class III device, reviewed by the Orthopedic panel.
What device class is NBN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NBN
- Run a recall and safety report across every NBN manufacturer
- Watch product code NBN 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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