# Cranial Electrotherapy Stimulator To Treat Depression
> **Product code: JXK** · Class III — High Risk (PMA approval required, life-sustaining) · Neurology · 21 CFR 882.5800
## Classification
- **FDA Product Code:** JXK
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 882.5800
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=JXK)
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