FDA product code MFR: Stimulator, Brain, Implanted, For Behavior Modification
MFR is the FDA product code for stimulator, brain, implanted, for behavior modification. It is a HDE device, reviewed by the Neurology panel. Devices under MFR reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Brain, Implanted, For Behavior Modification |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for MFR devices
openFDA lists no recalls for product code MFR.
Frequently asked questions
What is FDA product code MFR?
MFR is the FDA product code for stimulator, brain, implanted, for behavior modification. It is a HDE device, reviewed by the Neurology panel.
What device class is MFR?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code MFR
- Run a recall and safety report across every MFR manufacturer
- Watch product code MFR 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.