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Goniometer With Electrodes

FDA product code NKI · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.1500
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-01-23 – 2004-01-23

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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