FDA product code BRT: Restraint, Patient, Conductive
BRT is the FDA product code for restraint, patient, conductive. It is a Class I device, regulated under 21 CFR 880.6760 and reviewed by the General Hospital panel. Devices under BRT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Restraint, Patient, Conductive |
| Device class | Class I |
| Regulation | 21 CFR 880.6760 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for BRT devices
openFDA lists no recalls for product code BRT.
Frequently asked questions
What is FDA product code BRT?
BRT is the FDA product code for restraint, patient, conductive. It is a Class I device, regulated under 21 CFR 880.6760 and reviewed by the General Hospital panel.
What device class is BRT?
Class I, regulation 21 CFR 880.6760. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code BRT
- Run a recall and safety report across every BRT manufacturer
- Watch product code BRT 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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