FDA product code MKD: Stimulator, Functional Walking Neuromuscular, Non-Invasive
MKD is the FDA product code for stimulator, functional walking neuromuscular, non-invasive. It is a Class III device, reviewed by the Neurology panel. Devices under MKD 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 | Stimulator, Functional Walking Neuromuscular, Non-Invasive |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MKD devices
openFDA lists no recalls for product code MKD.
Frequently asked questions
What is FDA product code MKD?
MKD is the FDA product code for stimulator, functional walking neuromuscular, non-invasive. It is a Class III device, reviewed by the Neurology panel.
What device class is MKD?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MKD
- Run a recall and safety report across every MKD manufacturer
- Watch product code MKD 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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