FDA product code FQJ: Support, Scrotal, Therapeutic
FQJ is the FDA product code for support, scrotal, therapeutic. It is a Class I device, regulated under 21 CFR 880.5820 and reviewed by the General Hospital panel. Devices under FQJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Support, Scrotal, Therapeutic |
| Device class | Class I |
| Regulation | 21 CFR 880.5820 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for FQJ devices
openFDA lists no recalls for product code FQJ.
Frequently asked questions
What is FDA product code FQJ?
FQJ is the FDA product code for support, scrotal, therapeutic. It is a Class I device, regulated under 21 CFR 880.5820 and reviewed by the General Hospital panel.
What device class is FQJ?
Class I, regulation 21 CFR 880.5820. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code FQJ
- Run a recall and safety report across every FQJ manufacturer
- Watch product code FQJ 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times