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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device goniometer with electrodes
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.
Product CodeNKI
Regulation Number 888.1500
Device Class 2