FDA product code SDX: Neuromuscular Stimulator And Exercise Evaluation System
SDX is the FDA product code for neuromuscular stimulator and exercise evaluation system. It is a Class II device, regulated under 21 CFR 882.1871 and reviewed by the Neurology panel. Devices under SDX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions.
Classification
| Field | Value |
|---|---|
| Device name | Neuromuscular Stimulator And Exercise Evaluation System |
| Device class | Class II |
| Regulation | 21 CFR 882.1871 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SDX devices
openFDA lists no recalls for product code SDX.
Frequently asked questions
What is FDA product code SDX?
SDX is the FDA product code for neuromuscular stimulator and exercise evaluation system. It is a Class II device, regulated under 21 CFR 882.1871 and reviewed by the Neurology panel.
What device class is SDX?
Class II, regulation 21 CFR 882.1871. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SDX
- Run a recall and safety report across every SDX manufacturer
- Watch product code SDX 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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