FDA product code PIA: Vibrator For Climax Control Of Premature Ejaculation
PIA is the FDA product code for vibrator for climax control of premature ejaculation. It is a Class II device, regulated under 21 CFR 876.5025 and reviewed by the Gastroenterology and Urology panel. Devices under PIA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Vibrator for climax control training for the treatment of premature ejaculation.
Classification
| Field | Value |
|---|---|
| Device name | Vibrator For Climax Control Of Premature Ejaculation |
| Device class | Class II |
| Regulation | 21 CFR 876.5025 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PIA devices
openFDA lists no recalls for product code PIA.
Frequently asked questions
What is FDA product code PIA?
PIA is the FDA product code for vibrator for climax control of premature ejaculation. It is a Class II device, regulated under 21 CFR 876.5025 and reviewed by the Gastroenterology and Urology panel.
What device class is PIA?
Class II, regulation 21 CFR 876.5025. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PIA
- Run a recall and safety report across every PIA manufacturer
- Watch product code PIA 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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