FDA product code KAJ: Mobilizer, Ent
KAJ is the FDA product code for mobilizer, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. Devices under KAJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Mobilizer, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for KAJ devices
openFDA lists no recalls for product code KAJ.
Frequently asked questions
What is FDA product code KAJ?
KAJ is the FDA product code for mobilizer, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KAJ?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KAJ
- Run a recall and safety report across every KAJ manufacturer
- Watch product code KAJ 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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