FDA product code PXF: Sitz Bath Kit
PXF is the FDA product code for sitz bath kit. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel. Devices under PXF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Sitz Bath Kit |
| Device class | Class I |
| Regulation | 21 CFR 880.6730 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PXF devices
openFDA lists no recalls for product code PXF.
Frequently asked questions
What is FDA product code PXF?
PXF is the FDA product code for sitz bath kit. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel.
What device class is PXF?
Class I, regulation 21 CFR 880.6730. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXF
- Run a recall and safety report across every PXF manufacturer
- Watch product code PXF 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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