FDA product code KRF: Charger, Pacemaker
KRF is the FDA product code for charger, pacemaker. It is a Class I device, regulated under 21 CFR 870.3670 and reviewed by the Cardiovascular panel. Devices under KRF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Charger, Pacemaker |
| Device class | Class I |
| Regulation | 21 CFR 870.3670 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for KRF devices
openFDA lists no recalls for product code KRF.
Frequently asked questions
What is FDA product code KRF?
KRF is the FDA product code for charger, pacemaker. It is a Class I device, regulated under 21 CFR 870.3670 and reviewed by the Cardiovascular panel.
What device class is KRF?
Class I, regulation 21 CFR 870.3670. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KRF
- Run a recall and safety report across every KRF manufacturer
- Watch product code KRF 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.