# Electromyograph, Diagnostic
> **Product code: IKN** · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.1375
## Classification
- **FDA Product Code:** IKN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 890.1375
- **Review panel:** NE
- **Medical specialty:** Physical Medicine
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Market data
- **Cleared 510(k) submissions:** 75
- **Registered establishments:** 70
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=IKN)
---
*AI Analytics · CC0 1.0*