FDA product code NYW: Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYW is the FDA product code for stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. Devices under NYW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Nerve stimulation for relief of pain
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NYW devices
openFDA lists no recalls for product code NYW.
Frequently asked questions
What is FDA product code NYW?
NYW is the FDA product code for stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is NYW?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NYW
- Run a recall and safety report across every NYW manufacturer
- Watch product code NYW 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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