FDA product code MRU: Implanted Subcortical Electrical Stimulator (Motor Disorders)
MRU is the FDA product code for implanted subcortical electrical stimulator (motor disorders). It is a HDE device, reviewed by the Neurology panel. Devices under MRU reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for MRU devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Implanted Subcortical Electrical Stimulator (Motor Disorders) |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for MRU devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-03-30.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code MRU?
MRU is the FDA product code for implanted subcortical electrical stimulator (motor disorders). It is a HDE device, reviewed by the Neurology panel.
What device class is MRU?
HDE. Typical premarket route: Unclassified.
Have MRU devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MRU
- Run a recall and safety report across every MRU manufacturer
- Watch product code MRU 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.