FDA product code LHP: System, Telethermographic (Sole Diagnostic Screen)
LHP is the FDA product code for system, telethermographic (sole diagnostic screen). It is a Class III device, regulated under 21 CFR 884.2980 and reviewed by the Radiology panel. Devices under LHP reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | System, Telethermographic (Sole Diagnostic Screen) |
| Device class | Class III |
| Regulation | 21 CFR 884.2980 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for LHP devices
openFDA lists no recalls for product code LHP.
Frequently asked questions
What is FDA product code LHP?
LHP is the FDA product code for system, telethermographic (sole diagnostic screen). It is a Class III device, regulated under 21 CFR 884.2980 and reviewed by the Radiology panel.
What device class is LHP?
Class III, regulation 21 CFR 884.2980. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LHP
- Run a recall and safety report across every LHP manufacturer
- Watch product code LHP 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.