# Goniometer With Electrodes
> **Product code: NKI** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.1500
## Classification
- **FDA Product Code:** NKI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.1500
- **Review panel:** NE
- **Medical specialty:** Orthopedic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A goniometer is an AC-powered or battery powered  device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NKI)
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