FDA product code FIA: Chair, Dialysis, Unpowered, Without Scales
FIA is the FDA product code for chair, dialysis, unpowered, without scales. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. Devices under FIA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Dialysis, Unpowered, Without Scales |
| Device class | Class I |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for FIA devices
openFDA lists no recalls for product code FIA.
Frequently asked questions
What is FDA product code FIA?
FIA is the FDA product code for chair, dialysis, unpowered, without scales. It is a Class I device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIA?
Class I, regulation 21 CFR 876.5820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FIA
- Run a recall and safety report across every FIA manufacturer
- Watch product code FIA 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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