FDA product code HPH: Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
HPH is the FDA product code for diathermy, microwave, for use other than applying therapeutic deep heat. It is a Class III device, regulated under 21 CFR 890.5275 and reviewed by the Physical Medicine panel. Devices under HPH reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
PMAs to be filed by 7/13/99 (64 FR 18331 (4/14/99))
Classification
| Field | Value |
|---|---|
| Device name | Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device class | Class III |
| Regulation | 21 CFR 890.5275 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | PMA |
Recalls for HPH devices
openFDA lists no recalls for product code HPH.
Frequently asked questions
What is FDA product code HPH?
HPH is the FDA product code for diathermy, microwave, for use other than applying therapeutic deep heat. It is a Class III device, regulated under 21 CFR 890.5275 and reviewed by the Physical Medicine panel.
What device class is HPH?
Class III, regulation 21 CFR 890.5275. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HPH
- Run a recall and safety report across every HPH manufacturer
- Watch product code HPH 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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