FDA product code JXK: Cranial Electrotherapy Stimulator To Treat Depression
JXK is the FDA product code for cranial electrotherapy stimulator to treat depression. It is a Class III device, regulated under 21 CFR 882.5800 and reviewed by the Neurology panel. Devices under JXK reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 3 recalls for JXK devices.
Classification
| Field | Value |
|---|---|
| Device name | Cranial Electrotherapy Stimulator To Treat Depression |
| Device class | Class III |
| Regulation | 21 CFR 882.5800 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
Recalls for JXK devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-10-29.
Frequently asked questions
What is FDA product code JXK?
JXK is the FDA product code for cranial electrotherapy stimulator to treat depression. It is a Class III device, regulated under 21 CFR 882.5800 and reviewed by the Neurology panel.
What device class is JXK?
Class III, regulation 21 CFR 882.5800. Typical premarket route: PMA.
Have JXK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2007-10-29.
Next steps
- Run an FDA pathway report with predicate devices for product code JXK
- Run a recall and safety report across every JXK manufacturer
- Watch product code JXK 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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