FDA product code LXF: Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
LXF is the FDA product code for diathermy, ultrasonic, for use other than applying therapeutic deep heat. It is a Class III device, regulated under 21 CFR 890.5300 and reviewed by the Physical Medicine panel. Devices under LXF reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat |
| Device class | Class III |
| Regulation | 21 CFR 890.5300 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | PMA |
Recalls for LXF devices
openFDA lists no recalls for product code LXF.
Frequently asked questions
What is FDA product code LXF?
LXF is the FDA product code for diathermy, ultrasonic, for use other than applying therapeutic deep heat. It is a Class III device, regulated under 21 CFR 890.5300 and reviewed by the Physical Medicine panel.
What device class is LXF?
Class III, regulation 21 CFR 890.5300. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LXF
- Run a recall and safety report across every LXF manufacturer
- Watch product code LXF 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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