NKI

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Goniometer With Electrodes

Device class

Class II (moderate risk)

Regulation

21 CFR 888.1500

Medical specialty

Orthopedic

FDA 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.

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