FDA 510(k), K201906, Trinity ELE Plus and Trinity ELE Plus Pro

FDA 510(k), K201906, Trinity ELE Plus and Trinity ELE Plus Pro

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510(K) Number: K201906
Device Name: Trinity ELE Plus and Trinity ELE Plus Pro
Manufacturer: Carol Cole Company dba NuFACE
Device Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation Number: 882.5890
Classification Product Code: NFO
Date Received: 07/09/2020
Decision Date: 02/24/2021
Regulation Medical Specialty: Neurology

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