NKI · Class II · 21 CFR 888.1500

FDA Product Code NKI: Goniometer With Electrodes

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.

Leading manufacturers include Friendly Sensors AG.

Total

Cleared

113d

Avg days

2004

Since

FDA 510(k) Cleared Goniometer With Electrodes Devices (Product Code NKI)

1 devices

1–1 of 1

About Product Code NKI - Regulatory Context

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Data Source

FDA 510(k) public files . 176,583 total devices indexed.

Latest clearance: Jan 23, 2004

Product Code Info

Code	NKI
Device class	Class II
CFR	21 CFR 888.1500
Panel	Neurology

Verify on FDA.gov

View NKI classification on FDA.gov →