FDA product code NKI

Goniometer With Electrodes

Orthopedic·Class 2·21 CFR 888.1500
US regulatory classifications
US Product Code (FDA)
NKI
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.1500
View CFR Regulation →
Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Goniometer With Electrodes is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.