NKI

Goniometer With Electrodes

Product code

NKI

Device name

Goniometer With Electrodes

Device class

Class 2

21 CFR

21 CFR 888.1500

Medical specialty

Orthopedic

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).