FDA product code HEH: Chamber, Decompression, Abdominal
HEH is the FDA product code for chamber, decompression, abdominal. It is a Class III device, regulated under 21 CFR 884.5225 and reviewed by the Obstetrics and Gynecology panel. Devices under HEH reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Decompression, Abdominal |
| Device class | Class III |
| Regulation | 21 CFR 884.5225 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HEH devices
openFDA lists no recalls for product code HEH.
Frequently asked questions
What is FDA product code HEH?
HEH is the FDA product code for chamber, decompression, abdominal. It is a Class III device, regulated under 21 CFR 884.5225 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEH?
Class III, regulation 21 CFR 884.5225. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HEH
- Run a recall and safety report across every HEH manufacturer
- Watch product code HEH 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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