FDA product code HHA: Heater, Perineal, Radiant, Non-Contact
HHA is the FDA product code for heater, perineal, radiant, non-contact. It is a Class II device, regulated under 21 CFR 884.5390 and reviewed by the Obstetrics and Gynecology panel. Devices under HHA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Heater, Perineal, Radiant, Non-Contact |
| Device class | Class II |
| Regulation | 21 CFR 884.5390 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for HHA devices
openFDA lists no recalls for product code HHA.
Frequently asked questions
What is FDA product code HHA?
HHA is the FDA product code for heater, perineal, radiant, non-contact. It is a Class II device, regulated under 21 CFR 884.5390 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHA?
Class II, regulation 21 CFR 884.5390. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HHA
- Run a recall and safety report across every HHA manufacturer
- Watch product code HHA 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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